Your browser does not support JavaScript! DRISTAN COLD MULTISYMPTOM (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL) TABLET [PFIZER CONSUMER HEALTHCARE]
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DRISTAN COLD MULTISYMPTOM (acetaminophen, chlorpheniramine maleate, phenylephrine hcl) tablet
[Pfizer Consumer Healthcare]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

ACTIVE INGREDIENTS (IN EACH TABLET)

Acetaminophen, USP 325 mg

Chlorpheniramine maleate, USP 2 mg

Phenylephrine HCl, USP 5 mg

PURPOSES

Pain reliever/Fever reducer

Antihistamine

Nasal decongestant

USES

  • 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

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

  • 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.

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
  • glaucoma
  • a breathing problem such as emphysema, asthma, or chronic bronchitis

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
  • taking sedatives or tranquilizers

When using this product

  • 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

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, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

QUESTIONS OR COMMENTS?

Call weekdays from 9 AM to 5 PM EST at 1-800-535-0026

PRODUCT PACKAGING

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

See new warnings information

Dristan Cold

Acetaminophen >> Pain reliever/Fever reducer

Chlorpheniramine maleate >> Antihistamine

Phenylephrine HCl >> Nasal Decongestant

Multi-symptom formula

For relief of Nasal Congestion, Sinus Pressure, Headache, Aches and Pains, Fever, Runny Nose and Sneezing

20 COATED TABLETS

Tablets individually blister sealed. If seal is broken, Do Not Use.

Wyeth Consumer Healthcare

Madison, NJ 07940 USA

Made in Canada ©2009 Wyeth

For most recent product information, visit www.dristan.com

Dristan Cold Packaging
DRISTAN COLD MULTISYMPTOM 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0573-1238
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen325 mg
chlorpheniramine maleate (chlorpheniramine ) chlorpheniramine maleate2 mg
phenylephrine hydrochloride (phenylephrine ) phenylephrine hydrochloride5 mg
Product Characteristics
ColorYELLOW (Upper Yellow Layer) , WHITE (Bottom White Layer) Scoreno score
ShapeROUND (Round film-coated tablet) Size5mm
FlavorImprint Code d
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0573-1238-212 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/05/2005
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIBusiness Operations
Wyeth Canada206472008MANUFACTURE, ANALYSIS

Revised: 6/2010
 
Pfizer Consumer Healthcare

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