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DAY & NIGHT NURSE CAPSULES

Active substance(s): DEXTROMETHORPHAN HYDROBROMIDE / PARACETAMOL / PHOLCODINE / PROMETHAZINE HYDROCHLORIDE / PSEUDOEPHEDRINE HYDROCHLORIDE

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Transcript
SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Day & Night Nurse Capsules

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Day Nurse Capsules
Active Ingredient

mg/cap

Paracetamol

500

Pseudoephedrine hydrochloride

30

Pholcodine

5

Night Nurse Capsules
mg/cap

Active Ingredient
Paracetamol

500

Promethazine hydrochloride

10

Dextromethorphan hydrobromide

7.5

For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Capsule, hard
The Day capsule has an orange cap and yellow body printed ‘Day Nurse’ in black ink
on the cap and the body.
The Night capsule has a green cap and white body printed ‘Night Nurse’ in black ink
on the cap and the body.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of colds, chills and influenza during the day.
For the symptomatic relief of colds, chills and influenza at night.

4.2.

Posology and Method of Administration
For oral administration.
Do not exceed the stated dose
Should not be used with other paracetamol-containing products; decongestants
antihistamine containing products (including those used on the skin) or cough
and cold medicines.
Not to be given to children under 12 years of age
Day Capsules
Adults and children aged 12 years and over
Two capsules every four hours, up to a maximum of three doses in any 24
hour period. Minimum dosing interval: 4 hours
Night Capsules
Adults and children aged 12 years and over
Two capsules just before bedtime. Only one dose should be taken at night.
Allow at least 4 hours between taking last dose of Day capsules and the dose
of Night capsules.

Elderly
There is no specific requirement for dosage reduction in the elderly. However.
the product should not be taken by elderly patients with confusion. The
elderly may be more susceptible to adverse effects including confusion and
paradoxical excitation with this medicine.
Do not use for longer than 3 days without medical advice.

4.3

Contraindications
This product is contraindicated in:


Hypersensitivity to any of the ingredients or excipients



Hyperexcitability.



Patients who are receiving monoamine oxidase inhibitors (MAOIs) or for two
weeks after stopping the MAOI drug.



Severe hypertension or severe coronary artery disease



Patients with or at risk of developing, respiratory failure (e.g. those with
chronic obstructive airways disease or pneumonia, or during an asthma attack
or an exacerbation of asthma).



Severe renal impairment.



Patients with bronchiolitis or bronchiectasis, due to sputum retention.



Patients who are receiving other sympathomimetics (such as decongestants,
appetite suppressants and amphetamine-like psychostimulants)

4.4.

Special Warnings and Precautions for Use
Medical advice must be sought before taking this product in people
with:


Hepatic impairment. Underlying liver disease increases the risk of
paracetamol-related liver damage.



Mild to moderate renal impairment



Chronic or persistant cough, such as occurs with asthma and emphysema, or
where cough is accompanied by excessive secretions.



Glaucoma



Hypertension or cardiovascular problems including arrhythmia



Prostatic hypertrophy



Urinary retention



Epilepsy



Diabetes



Hyperthyroidism



Phaechromocytoma

There have been rare cases of posterior reversible encephalopathy (PRES)/reversible
cerebral vasoconstriction syndrome (RCVS) reported with sympathomimetic drugs,
including pseudoephedrine. Symptoms reported included sudden onset of severe
headache, nausea, vomiting, and visual disturbances. Most cases improved or
resolved within a few days following appropriate treatment. Pseudoephedrine should
be discontinued immediately and medical advice sought if signs/symptoms of
PRES/RCVS develop.
Use with caution in the elderly, who are more likely to experience anticholinergic
adverse effects including confusion and paradoxical excitation. Avoid use in elderly
patients with confusion.
Children are more likely to experience paradoxical excitation with sedating
antihistamine.
Medical advice should be sought if symptoms persist, or are accompanied by high
fever, skin rash or persistent headache.
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption should not take this product.

Contains paracetamol.
Do not exceed the stated dose.
Alcohol should be avoided.
If symptoms persist, medical advice should be sought.
Should not be used with other paracetamol-containing products; decongestants
antihistamine containing products (including those used on the skin) or cough and
cold medicines

Keep out of reach and sight ofchildren.
Special label warnings
Immediate medical advice should be sought in the event of an overdose, even if you
feel well.
Do not take with any other paracetamol-containing products. Do not take with other
flu, cold or decongestant products.
Special leaflet warnings
Immediate medical advice should be sought in the event of an overdose, even if you
feel well, because of the risk of delayed, serious liver damage.

4.5

Interaction with other medicinal products and other forms of interaction

Medical advice should be sought before taking paracetamol-pseudoephedrinePholcodine (Day capsules) in combination with these drugs:
Monoamine-oxidase inhibitors

Should not be given to patients being

(MAOIs)

CNS depressant drugs such as
barbiturates, hypnotics, narcotic
analgesics, sedatives and
tranquillisers

treated with monoamine oxidase
inhibitors or within 14 days of stopping
such treatment as may lead to
hypertensive crisis
Pholcodine may enhance the sedative
effect of central nervous system
depressants.

Neuromuscular blocking agents

Pholcodine may predispose patients to
developing anaphylaxis with
neuromuscular blocking agents.

Alcohol

Concomitant use of alcohol with
pholcodine may increase the CNS
depressant effects of these drugs.

Warfarin and other coumarins

The anticoagulant effect of warfarin and
other coumarins may be enhanced by
prolonged regular daily use of
paracetamol with increase risk of
bleeding; occasional doses have no
significant effect.

Metoclopramide or domperidone

The speed of absorption of paracetamol
may be increased by metoclopramide or
domperidone and absorption reduced by
colestyramine

Antihypertensive drugs

Pseudoephedrine may diminish the
antihypertensive effects of
antihypertensive drugs (i.e beta-blockers,
methyl-dopa, reserpine debrisoquine)
Pseudoephedrine may increase the
possibility of arrhythmias in digitalised
patients.

Digoxin

Sympathomimetic agents (such
as decongestants, appetite
suppressants and amphetaminelike psychostimulants)

Concomitant use of this medication with
sympathomimetic agents which interfere
with the catabolism of sympathomimietic
amines, may occasionally cause a rise in
blood pressure.

Medical advice should be sought before taking paracetamol-promethazinedextromethorphan (Night capsules) in combination with these drugs:
Monoamine-oxidase inhibitors

Severe reactions, including serotonin
syndrome (see below), may occur when

(MAOIs)

this product is taken concomitantly, or
within two weeks of taking, an MAOI.
MAOIs may prolong and intensify the
anticholinergic effects of antihistamines.

Selective serotonin re-uptake
inhibitors (SSRIs), tricylic
antidepressants or MAOIs

Concomitant use of dextromethorphan
with selective serotonin re-uptake
inhibitors (SSRIs), tricyclic
antidepressants, or MAOIs may result in
serotonin syndrome with changes in
mental status, hypertension, restlessness,
myoclonus, hyperreflexia, diaphoresis,
shivering and tremor.

Anticholinergic drugs such as
atropine, MAOIs and tricyclic
antidepressants

As promethazine has some
anticholinergic activity, the effects of
some anticholinergic drugs may be
potentiated.

Alcohol

Concomitant use of alcohol with
dextromethorphan and promethazine
may increase the CNS depressant effects
of these drugs.

CNS depressant drugs such as
antipsychotics, hypnotics or
anxiolytics

Promethazine may potentiate the
sedative effects of other CNS depressant
drugs.

Warfarin and other coumarins

The anticoagulant effect of warfarin and
other coumarins may be enhanced by
prolonged regular daily use of
paracetamol with increase risk of
bleeding; occasional doses have no
significant effect.

Inhibitors of cytochrome P450
2D6

Serum levels of dextromethorphan may
be increased by the concomitant use of
inhibitors of cytochrome P450 2D6, such
as the antiarrhythmics quinidine and
amiodarone, antidepressants such as
fluoxetine and paroxetine, or other drugs
which inhibit cytochrome P450 2D6 such
as haloperidol and thioridazine.

Metoclopramide or domperidone

The speed of absorption of paracetamol
may be increased by metoclopramide or
domperidone and absorption reduced by
colestyramine

Promethazine (ingredient of Night Nurse capsules) may interfere with
immunologic urine pregnancy tests to produce false results

4.6.

Fertility, pregnancy and lactation
Pregnancy
The product (both Day and Night Capsules) should not be used during
pregnancy without medical advice.
Safe use of pseudoephedrine and pholcodine in pregnancy has not been
established despite widespread use over many years. Caution should therefore
be exercised by balancing the potential benefit of treatment to the mother
against any possible hazards to the developing foetus.
In view of the possible association of foetal abnormalities with first trimester
exposure to pseudoephedrine, this product should not be used during
pregnancy without medical advice.
Epidemiological studies in human pregnancy have shown no ill effects due to
paracetamol used in the recommended dosage, but patients should follow the
advice of their doctor regarding its use.
No relevant data are available for products containing dextromethorphan.
Human and animal studies with promethazine are insufficient to establish the
safety of this drug during pregnancy. It should only be used when considered
essential by the doctor

Lactation
This product (both Day and Night Capsules) should not be used whilst breast
feeding without medical advice.
Pseudoephedrine is secreted into breast milk in small amounts but the effect of
this on breast fed infants is unknown. The safety of pseudoephedrine and
pholcodine during lactation has not been established and therefore the product
should not be used during this period.
Paracetamol is excreted in breast milk but not in a clinically significant
amount.
Promethazine may be excreted in breast milk. It should only be used when
considered essential by a doctor.

4.7

Effects on ability to drive and use machines
The day capsule may cause dizziness. Patients should be advised not to drive
or operate machinery if affected.
The night capsule may cause drowsiness, dizziness, blurred vision, cognitive
and psychomotor impairment which can seriously affect the ability to drive
and use machinery. If affected do not drive or operate machinery.
This class of medicine is in the list of drugs included in regulations under 5a of
the Road Traffic Act 1988. When taking this medicine, patients should be told:





4.8

The medicine is likely to affect your ability to drive
Do not drive until you know how the medicine affects you
It is an offence to drive while under the influence of this medicine
However, you would not be committing an offence (called ‘statutory defence’)
if:
o The medicine has been taken to treat a medical or dental problem and
o You have taken it according to the information provided with the medicine
and
o It was not affecting your ability to drive safely.
Undesirable effects

The following convention has been utilized for the classification of
undesirable effects: very common (≤ 1/10), common (≤ 1/100, <1/10),
uncommon (≤ 1/1000, < 1/100), rare (≤ 1/10,000, < 1/1000), very rare
(<1/10,000), not known (cannot be estimated from available data).

Paracetamol (ingredient included in Day and Night capsule)
Adverse events of paracetamol from historical clinical trial data are both
infrequent and from small patient exposure. Accordingly, events reported from
extensive post-marketing experience at therapeutic/labelled dose and
considered attributable are tabulated below by system class. The frequency of
these adverse is not known (cannot be estimated from available data).

Body System
Blood and lymphatic system
disorders
Immune system disorders

Respiratory thoracic and

Undesirable effect
Thrombocytopenia
Anaphylaxis
Cutaneous hypersensitivity reactions
including skin rashes, angiodema and
Stevens Johnson syndrome/toxic
epidermal necrolysis
Bronchospasm*

mediastinal disorders
Hepatobiliary disorders

Hepatic dysfunction

*There have been cases of bronchospasm with paracetamol, but these are more
likely in asthmatics sensitive to aspirin or other NSAIDs.
Dextromethorphan (ingredient included in Night capsule only)
The following adverse events have been observed in published clinical studies
and are likely to represent uncommon adverse reactions to dextromethorphan.
Body system

Undesirable effect

Nervous system disorders

Drowsiness, dizziness

Gastrointestinal disorders

Gastrointestinal disturbance, nausea,
vomiting, abdominal discomfort

Adverse reaction identified during post-marketing use with dextromethorphan
are listed below. The frequency of these reactions is unknown but likely to be
very rare.
Body system

Undesirable effect

Immune system disorders

Allergic reactions (e.g. rash, urticaria,
angiodema)

Nervous system disorders

Serotonin syndrome (with changes in
mental status, restlessness,
myoclonus, hyperreflexia,
diaphoresis, shivering, tremor and
hypertension) has been reported when
dextromethorphan has been taken
concurrently with MAOIs or
serotonergic drugs such as SSRIs

Promethazine (ingredient included in Night capsule only)
Adverse reactions which been observed in published clinical studies with
promethazine and which are considered to be common or very common are
listed below by MedDRA system Organ Class. The frequency of other
reactions identified during post-marketing use is not known, but these
reactions are likely to be uncommon or rare.
Body System

Undesirable effect

Immune system disorders

Not known: Hypersensitivity
reactions including rash, urticaria,
angiodema and anaphylaxis,
photosensitivty

Psychiatric disorders

Not known: Confusion*,
disorientation*, paradoxical
excitation*, **(e.g. increased energy,
irritability, restlessness, nervousness,
sleep disturbance)
*The elderly are more susceptible to
confusion, disorientation and
paradoxical excitation
**Children are more susceptible to
paradoxical excitation

Nervous system disorders

Very common: Drowsiness
Common: Psychomotor impairment,
disturbance in attention, dizziness,
headache.

Eye disorders

Common: Blurred vision

Gastrointestinal disorders

Common: Dry mouth
Not Known: Gastrointestinal
disturbance

Renal and urinary disorders

Not known: Urinary retention

The elderly are more susceptible to anticholinergic effects of promethazine.
Pseudoephedrine (included in Day capsule only)
The frequency of reactions identified during post-marketing use is not known.
Body System
Psychiatric disorders

Nervous System Disorders

Undesirable effect
Nervousness, insomnia
Blurred vision
Agitation, restlessness
Hallucinations (particularly in
children)
Nightmares
Dizziness

Cardiac Disorders
Vascular Disorders
Gastrointestinal Disorders

Skin and subcutaneous tissue
disorders
Renal and Urinary Disorders

Headache, tinnitus, irritability,
tremor
Tachycardia, palpitations
Increased blood pressure*
Vomiting, dry mouth, nausea
Diarrhoea or constipation, epigastric
pain, anorexia
Rash, allergic dermatitis**
Dysuria, urinary retention***
Micturition difficulty

*Increases in systolic blood pressure have been observed. At therapeutic doses,
the effects of pseudoephedrine on blood pressure are not clinically significant.
**A variety of allergic skin reactions, with or without systemic features such as
bronchospasm and angioedema have been reported following use of
pseudoephedrine
***Urinary retention is most likely to occur in those with bladder outlet
obstruction, such as prostatic hypertrophy.
Pholcodine (ingredient included in Day capsule only)
The frequency of reactions identified during post-marketing use is not known
Body System
Immune System disorders
Gastrointestinal Disorders

4.9

Undesirable effect
Hypersensitivity reactions including
skin rashes, angioedema, anaphylaxis
Nausea vomiting

Overdose

Overdose
Paracetamol (ingredient included in Day and Night capsule)
Liver damage is possible in adults who have taken 10g or more of
paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage
if the patient has risk factors (see below).
Risk factors:
If the patient
a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin,

primidone, rifampicin, St John’s Wort or other drugs that induce liver
enzymes.
Or
b, Regularly consumes ethanol in excess of recommended amounts.
Or
c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV
infection, starvation, cachexia.
Symptoms:
Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea,
vomiting, anorexia and abdominal pain. Liver damage may become apparent
12 to 48 hours after ingestion. Abnormalities of glucose metabolism and
metabolic acidosis may occur. In severe poisoning, hepatic failure may
progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema,
and death. Acute renal failure with acute tubular necrosis, strongly suggested
by loin pain, haematuria and proteinuria, may develop even in the absence of
severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.
Management:
Immediate treatment is essential in the management of paracetamol overdose.
Despite a lack of significant early symptoms, patients should be referred to
hospital urgently for immediate medical attention. Symptoms may be limited
to nausea or vomiting and may not reflect the severity of overdose or the risk
of organ damage. Management should be in accordance with established
treatment guidelines, see BNF overdose section.
Treatment with activated charcoal should be considered if the overdose has
been taken within 1 hour. Plasma paracetamol concentration should be
measured at 4 hours or later after ingestion (earlier concentrations are
unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after
ingestion of paracetamol, however, the maximum protective effect is obtained
up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply
after this time. If required the patient should be given intravenous Nacetylcysteine, in line with the established dosage schedule. If vomiting is not
a problem, oral methionine may be a suitable alternative for remote areas,
outside hospital. Management of patients who present with serious hepatic
dysfunction beyond 24h from ingestion should be discussed with the NPIS or a
liver unit.
Dextromethorphan (ingredient included in Day capsule only)
Symptoms:
Overdose is likely to result in effects similar to those listed under Adverse
Reactions. The effects in overdosage will be potentiated by simultaneous
ingestion of alcohol and psychotropic drugs. Following large overdoses,
additional symptoms may include excitation, mental confusion, restlessness,
nervousness and irritability, stupor, ataxia, dystonia, hallucinations, psychosis
and respiratory depression.
Management:

Supportive and symptomatic care should be provided as required. If overdose
is severe, nalaxone may be helpful, particulary for patients with respiratory
depression.

Pholcodine (ingredient included in Day capsule only)
Symptoms:
Overdose symptoms may include nausea, drowsiness, restlessness, excitement
and ataxia. The effects in overdosage will be potentiated by simultaneous
ingestion of alcohol and psychotropic drugs. Central nervous system
depression, including respiratory depression, may develop but is unlikely to be
severe unless other sedative agents have been co-ingested, including alcohol,
or the overdose is very large.
Management:
Supportive and symptomatic care should be provided as required. If overdose
is severe, nalaxone may be helpful, particulary for patients with respiratory
depression.
Pseudoephedrine Hydrocholride (ingredient included in Day capsules only).
Symptoms:
As with other sympathomimetics pseudoephedrine overdose will result in
symptoms due to central nervous system and cardiovascular stimulation e.g.
excitement, irritability, restlessness, tremor, hallucinations, hypertension,
palpitations,arrhythmias and difficulty with micturition. In severe cases,
psychosis, convulsions, coma and hypertensive crisis may occur. Serum
potassium levels may be low due to extracellular to intracellular shifts in
potassium.
Management:
Treatment should consist of standard supportive measures. Beta-blockers
should reverse the cardiovascular complications and the hypokalaemia.
Promethazine Hydrochloride(ingredient included in Night capsule only)

Symptoms:
Promethazine overdose is likely to result in effects similar to those listed under
Adverse Reactions. Additional symptoms may include delirium, agitation,
hallucinations, dystonic reactions, hypotension, and ECG changes. Large
overdose may cause convulsions, toxic psychosis, arrythmias, coma and
cardiorespiratory depression.

Management:
Treatment is supportive with attention to maintenance of adequate respiratory
and circulatory status. Convulsions and marked CNS stimulation should be
treated with parenteral diazepam or other suitable anti-convulsants.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Paracetamol - an analgesic and antipyretic.
Pseudoephedrine - a sympathomimetic agent with both direct and indirect effects on
adrenergic receptors.
Pholcodine – an antitussive with little analgesic activity.
Promethazine hydrochloride – an antihistamine with anticholinergic activity.
Dextromethorphan hydrobromide - an antitussive.

5.2

Pharmacokinetic properties
Paracetamol is readily absorbed from the gastrointestinal tract with peak plasma
concentrations occurring about 30 minutes to 2 hours after oral administration.
Paracetamol is distributed into most body tissues. It crosses the placenta and is
present in breast milk. Plasma protein binding is negligible at usual therapeutic
concentrations. Paracetamol is metabolised predominantly in the liver and excreted in
the urine mainly as the glucuronide and sulphate conjugates, with about 10% as
glutathione conjugates. Less than 5% is excreted as unchanged paracetamol. The
elimination half-life varies from about 1 to 4 hours.
Pseudoephedrine is absorbed from the gastrointestinal tract. It is resistant to
metabolism and is excreted largely unchanged in the urine. It has a half-life of several
hours but elimination is enhanced and half-life shortened in acid urine.
Pholcodine is rapidly absorbed after oral administration and maximum plasma
concentrations are attained at about 4-8 hours. The elimination half-life ranges from
32 to 43 hours. The drug has a large volume of distribution and is only 23.5% protein
bound. Pholcodine is metabolised in the liver but undergoes little conjugation with
glucuronide and sulphate.
Promethazine hydrochloride is readily absorbed from the gastrointestinal tract, but
undergoes extensive first pass metabolism in the liver, with only 25% of the oral dose
reaching the systemic circulation unchanged. After oral therapy therapeutic effects
are identifiable at 15-30 minutes and peak plasma concentrations at 2 to 3 hours.
Estimates of terminal half-life in blood plasma are in the range of 4-6 hours. It is
extensively plasma protein bound. It is eliminated mainly as metabolites,
predominantly by the faecal (via biliary) route, with < 1% of the parent compound
and ca. 10% as the sulphoxide metabolite being excreted in the urine over a 72 hour
period.

Dextromethorphan hydrobromide is well absorbed from the gastrointestinal tract. It is
metabolised in the liver and excreted as demethylated metabolites including
dextrorphan, and as a minor proportion of unchanged dextromethorphan. In a small
proportion of individuals, metabolism proceeds more slowly and dextromethorphan
predominates in blood and urine.

5.3

Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to
that already included.

6.

Pharmaceutical Particulars

6.1.

List of Excipient(s)
Day Nurse Capsules
Sodium lauryl sulphate
Sodium starch glycollate
Magnesium stearate (E572)
Hard gelatin capsule
Quinoline yellow (E104)
Allura red (E 129)
Titanium dioxide (E171)
Printing Ink:
Shellac
Isopropyl alcohol
Iron oxide black (E 172)
N-butyl alcohol
Propylene glycol (E 1520)
Ammonium hydroxide (E 527)
Night Nurse Capsules
Lactose monohydrate
Dimeticone
Colloidal anhydrous silica
Gelatin
Patent blue V (E131)
Quinoline yellow (E104)
Titanium dioxide (E171)
Printing Ink:
Shellac
Isopropyl alcohol
Iron oxide black (E 172)
N-butyl alcohol
Propylene glycol (E 1520)
Ammonium hydroxide (E 527)

6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25°C. Store in the original package.

6.5

Nature and contents of container
Blisters: 250 μm PVC/60gsm PVDC blister tray with 30 μm aluminium foil lid.
Each tray holds 6 Day Nurse capsules and 2 Night Nurse capsules.
Pack size: 24 capsules (3 trays) comprising 18 Day Nurse capsules and 6 Night
Nurse capsules.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Beecham Group plc
980 Great West Road
Brentford
Middlesex
TW8 9GS
United Kingdom
Trading as GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8

MARKETING AUTHORISATION NUMBER(S)
PL 00079/0387

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
18 July 2002

10

DATE OF REVISION OF THE TEXT
29/09/2014

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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