ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF
Dosage form: tablet
Ingredients: acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hydrochloride 5mg
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8732
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
[acetaminophen, chlorpheniramine maleate, and phenylephrine HCl]
Acetaminophen, USP 325 mg
Chlorpheniramine maleate, USP 2 mg
Phenylephrine HCl, USP 5 mg
Pain reliever/Fever reducer
Antihistamine
Nasal decongestant
- temporarily relieves these symptoms associated with a cold, or flu:
- headache
- nasal congestion
- sore throat
- fever
- minor aches and pains
- temporarily relieves minor aches, pains and headache as well as these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- nasal congestion
- itching of the nose or throat
- itchy, watery eyes
- temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 tablets in any 24-hour period, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
- to sedate a child or to make a child sleepy
- if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen ask a doctor or pharmacist.
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate gland
- glaucoma
- a breathing problem such as emphysema, asthma, or chronic bronchitis
- taking the blood thinning drug warfarin
- taking any other oral nasal decongestant or stimulant
- taking any other pain reliever/fever reducer
- taking sedatives or tranquilizers
- do not use more than directed
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
- you get nervous, dizzy, or sleepless
- pain or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
- do not use more than 12 tablets in any 24-hour period
- do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage
- this adult product is not intended for use in children under 12 years of age
| age | dose |
|---|---|
| adults and children 12 years and over | 2 tablets every 4 hours |
| children under 12 years | do not use |
- store at 20-25°C (68-77°F)
- tamper-evident individual blisters
calcium stearate, croscarmellose sodium, crospovidone, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid
Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675
The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.
NEW!
ADULT
Robitussin PEAK COLD NIGHTTIME Nasal Relief
ACETAMINOPHEN (Pain Reliever/Fever Reducer)
CHLORPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)
Relieves:
- Nasal Congestion
- Headache
- Sore Throat
- Runny Nose
For Ages 12 & Over
20 TABLETS
Tablets individually blister sealed. If seal is broken, Do Not Use.
For most recent product information, visit www.robitussin.com
Pfizer, Madison, NJ 07940 USA
© 2011 Pfizer Inc.
Made in Canada
| ROBITUSSIN PEAK COLD NIGHTTIME NASAL RELIEF
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet |
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| Labeler - Richmond Division of Wyeth (829390835) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pfizer Canada Inc. | 206472008 | MANUFACTURE, ANALYSIS, LABEL, PACK | |
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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
