ROBITUSSIN PEAK COLD NASAL RELIEF

Dosage form: tablet
Ingredients: acetaminophen 325mg, phenylephrine hydrochloride 5mg
Labeler: Richmond Division of Wyeth
NDC Code: 0031-8731

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.

Robitussin Peak Cold Nasal Relief
(acetaminophen, phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Acetaminophen, USP 325 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Pain reliever/Fever reducer

Nasal decongestant

USES
  • temporarily relieves these symptoms associated with a cold or flu, hay fever or other upper respiratory allergies:
    • nasal congestion
    • sinus congestion and pressure
    • reduces swelling of nasal passages
    • restores freer breathing through the nose
    • headache
    • sore throat
    • minor aches and pains
  • temporarily reduces fever

WARNINGS

Liver warning:

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

Sore throat warning:

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.

Do not use
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for2 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.

Ask a doctor before use if you have
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if you are
  • taking the blood thinning drug warfarin
  • taking any other oral nasal decongestant or stimulant
  • taking any other pain reliever/fever reducer

When using this product do not use more than directed

Stop use and ask a doctor if
  • 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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.

DIRECTIONS
  • 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
agedose
adults and children 12 years and over2 tablets every 4 hours
children under 12 yearsdo not use

OTHER INFORMATION
  • store at 20-25°C (68-77°F)
  • tamper-evident individual blisters

INACTIVE INGREDIENTS

calcium stearate, croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-762-4675

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

NEW!

ADULT

Robitussin PEAK COLD Nasal Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

PHENYLEPHRINE HCl (Nasal Decongestant)

Relieves:

  • Nasal Congestion
  • Headache
  • Sore Throat

Non-Drowsy

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 NASAL RELIEF 
acetaminophen, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-8731
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen325 mg
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride5 mg
Inactive Ingredients
Ingredient NameStrength
calcium stearate 
croscarmellose sodium 
crospovidone 
hypromelloses 
cellulose, microcrystalline 
polyethylene glycols 
povidone 
starch, corn 
stearic acid 
Product Characteristics
ColorWHITE (White) Scoreno score
ShapeROUND (round double layer tablet) Size10mm
FlavorImprint CodeRN
Contains    
Packaging
#Item CodePackage Description
1NDC:0031-8731-202 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/06/2011
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIOperations
Pfizer Canada Inc.206472008MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 12/2011
 
Richmond Division of Wyeth

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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