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Dallergy PE Syrup

Generic Name: phenylephrine hydrochloride, chlorpheniramine maleate, methscopolamine nitrate
Dosage Form: syrup

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Dallergy PE Syrup

Dallergy PE Syrup

Rx Only

DESCRIPTION:
Each 5 mL (1 teaspoonful) of Dallergy PE Syrup contains:
Phenylephrine Hydrochloride.................. 10 mg
Chlorpheniramine Maleate.....................   2 mg
Methscopolamine Nitrate.....................0.75 mg

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Phenylephrine hydrochloride is a decongestant having the chemical name Benzenemethanol,
3-hydroxy-α-[(methylamino) methyl]-, hydrochloride.

Chlorpheniramine maleate is an antihistamine having the chemical name 2-pyridinepropanamine,
γ-(4 chlorophenyl)-N, N-dimethyl-, (Z) -2-butenedioate (1:1).

Methscopolamine nitrate is an anticholinergic having the chemical name 3-Oxa-9-azoniatricyclo,
[3.3.1.0] nonane, 7-(3-hydroxy-1-oxo-2-phenylpropoxy)-9, 9-dimethyl-, nitrate,
[7(S)-(1α, 2β, 4β, 5α, 7β)]-.


Inactive ingredients:

Citric acid, FD and C Red #40, FD and C Blue No. 1, glycerin, grape flavoring, maltitol, propylene
glycol, purified water, sodium saccharin, and sorbitol.

DALLERGY® PE SYRUP contains ingredients of the following therapeutic classes: nasal
decongestant, antihistamine, and antisecretory agent.

CLINICAL PHARMACOLOGY:

Phenylephrine hydrochloride is a sympathomimetic which acts predominantly on alpha receptors and
has little action on beta receptors. It, therefore, functions as an oral nasal decongestant with minimal
CNS stimulation.

Chlorpheniramine maleate is an alkylamine type antihistamine. This group of antihistamines is among
the most active histamine antagonists and is generally effective in relatively low doses. The drugs are
not so prone to produce drowsiness and are among the most suitable agents for daytime use; but
again, a significant proportion of patients do experience this effect.

Methscopolamine nitrate is a quaternary ammonium derivative of scopolamine, which possesses the
peripheral actions of the belladonna alkaloids, but does not exhibit the central actions because of its
lack of ability to cross the blood-brain barrier. In this formulation, it is used because of its antisecretory
effects on the respiratory system.

INDICATIONS AND USAGE:

For the relief of upper respiratory symptoms associated with allergies and the common cold, such as:
nasal congestion, sinusitis, sneezing, lacrimation, vasomotor rhinitis, post-nasal drip, and hay fever.

CONTRAINDICATIONS:

Hypersensitivity to any of the ingredients. Also contraindicated in patients with severe hypertension,
severe coronary artery disease, patients on MAO inhibitor therapy, patients with narrow angle
glaucoma, urinary retention, peptic ulcer, and during an asthmatic attack.

WARNINGS:

Considerable caution should be exercised in patients with hypertension, diabetes mellitus, ischemic
heart disease, hyperthyroidism, increased intraocular pressure, and prostatic hypertrophy. The elderly
(60 years or older) are more likely to exhibit adverse reactions. Antihistamines may cause excitability,
especially in children. At dosages higher than the recommended dose, nervousness, dizziness, or
sleeplessness may occur.

PRECAUTIONS:

General:
Caution should be exercised in patients with high blood pressure, heart disease, diabetes, or thyroid
disease. The antihistamine in this product may exhibit additive effects with other CNS depressants,
including alcohol.

Information for patients:

Antihistamines may cause drowsiness, and ambulatory patients who operate machinery or motor
vehicles should be cautioned accordingly.

Drug interactions:

MAO inhibitors and beta adrenergic blockers increase the effects of sympathomimetics.
Sympathomimetics may reduce the antihypertensive effects of methyldopa, mecamylamine,
reserpine and veratrum alkaloids. Concomitant use of antihistamines with alcohol and other
CNS depressants may have an additive effect.

Pregnancy: Pregnancy Category C:

It is not known whether DALLERGY® PE SYRUP can cause fetal harm when administered to a
pregnant woman or can affect reproduction capacity. DALLERGY® PE SYRUP should be given
to a pregnant woman only if clearly needed.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted
in human milk, caution should be exercised when DALLERGY® PE SYRUP is administered to a
nursing woman.

Pediatric Use:

Safety and effectiveness of DALLERGY® PE SYRUP in children below the age of 6 have not been established.

ADVERSE REACTIONS:

Adverse reactions include drowsiness, lassitude, nausea, giddiness, dryness of mouth, blurred vision,
cardiac palpitations, flushing, increased irritability or excitement (especially in children).

OVERDOSAGE AND TREATMENT OF OVERDOSAGE:

In all cases of suspected overdose, immediately call your regional poison center, and/or contact a
physician immediately. The stomach should be emptied promptly by lavage or by induction of
emesis with syrup of ipecac. The installation of activated charcoal into the stomach also should be
considered. The treatment of overdose is essentially symptomatic and supportive. If respiratory
depression is present, treat promptly with oxygen and/or mechanical support of ventilation. If
convulsions or marked CNS excitement occurs, only short-acting benzodiazepine-type drugs should
be used.

DOSAGE AND ADMINISTRATION:

Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

HOW SUPPLIED:

16 fl oz (473 mL) (NDC 16477-821-01) and 1 fl oz (30 mL) (NDC 16477-821-30) bottles of purple
colored, grape flavored syrup.

Store at controlled room temperature 20o-25oC (68o-77oF). [See USP].

Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Manufactured by:
Great Southern Laboratories
Houston, TX 77099

Rx Only

R06/09

PRODUCT PACKAGING:

The packaging below represents the labeling currently used.

Principal Display Panel and Side Panel for 473 mL Label:

NDC: 16477-821-01

DALLERGY® PE SYRUP

Rx

Nasal Decongestant
Antihistamine
Antisecretory

Each 5 mL (1 teaspoonful) contains:
Phenylephrine Hydrochloride ........ 10 mg
Chlorpheniramine Maleate ............  2 mg
Methscopolamine Nitrate ............0.75 mg


Rx Only                   16 fl oz (473 mL)

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL) every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL) every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

For full prescribing information see attached insert.

Store at controlled room temperature 20o-25oC (68o-77oF).
[See USP].

Tamper-evident by foil seal under cap. Do not use if foil seal is broken or missing.

Dispense in a tight light-resistant container as defined in the USP/NF with a child-resistant closure.

WARNING:
Keep this and all drugs out of reach of children.


Manufactured for:                               Manufactured by:
Laser Pharmaceuticals, LLC        Great Southern Laboratories
Greenville, SC 29615                          Houston, TX 77099

R06/09

Principal Display Panel and Side Panel for 30mL Label:

NDC
16477-821-30

Dallergy
® PE Syrup
Rx

Nasal Decongetsant / Antihistamine
Antisecretory


Each 5 mL (1 teaspoonful) contains:
Phenylephrine Hydrochloride  10 mg
Chlorpheniramine Maleate  .... 2 mg
Methscopolamine Nitrate .. 0.75 mg



Rx Only           30 mL (1 fl. oz.)

DOSAGE AND ADMINISTRATION:
Adults and children 12 years of age and older:
2 teaspoonfuls (10 mL)
every 4 to 6 hours.
Children 6 to under 12 years of age:
1 teaspoonful (5 mL)
every 4 to 6 hours.
Children under 6 years of age:
Consult a physician.
Not to exceed 4 doses in 24 hours.

For full prescribing information see package insert.

Store at controlled room temperature, 20o-25oC (68o-77oF). [See USP].

WARNING:
Keep this and all drugs out of the reach of children.

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Manufactured for:
Laser Pharmaceuticals, LLC
Greenville, SC 29615

Manufactured by:
Great Southern Laboratories
Houston, TX 77099   Rev. 04/09






DALLERGY  PE SYRUP
phenylephrine hydrochloride, chlorpheniramine maleate, methscopolamine nitrate syrup
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16477-821
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Phenylephrine Hydrochloride (Phenylephrine) Phenylephrine Hydrochloride 10 mg  in 5 mL
Chlorpheniramine Maleate (Chlorpheniramine) Chlorpheniramine Maleate 2 mg  in 5 mL
Methscopolamine Nitrate (Methscopolamine) Methscopolamine Nitrate 0.75 mg  in 5 mL
Product Characteristics
Color      Score     
Shape Size
Flavor GRAPE Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:16477-821-01 473 mL in 1 BOTTLE
2 NDC:16477-821-30 30 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 04/30/2009
Labeler - Laser Pharmaceuticals LLC (614417132)
Registrant - Great Southern Laboratories (056139553)
Establishment
Name Address ID/FEI Operations
Great Southern Laboratories 056139553 manufacture
Revised: 09/2009
 
Laser Pharmaceuticals LLC



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