Your browser does not support JavaScript! CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) LIQUID [RICHMOND DIVISION OF WYETH]
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CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU (acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl) liquid
[Richmond Division of Wyeth]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not 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

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH 5 ML TSP)

Acetaminophen, USP 160 mg

Chlorpheniramine maleate, USP 1 mg

Dextromethorphan HBr, USP 5 mg

Phenylephrine HCl, USP 2.5 mg

PURPOSES

Pain reliever/Fever reducer

Antihistamine

Cough suppressant

Nasal decongestant

USES

  • temporarily relieves these symptoms associated with a cold, or flu:
    • headache
    • sore throat
    • fever
    • minor aches and pains
  • temporarily relieves nasal congestion, and cough due to minor throat and bronchial irritation occurring with a cold
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • sneezing
    • itching of the nose or throat
    • itchy, watery eyes
    • runny nose
  • temporarily restores freer breathing through the nose

WARNINGS

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if user takes

  • more than 5 doses 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
  • in a child under 6 years of age
  • if user is 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 user has

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if user is

  • 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
  • marked 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

  • user gets nervous, dizzy, or sleepless
  • pain, cough, or nasal congestion gets worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • 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 take more than 5 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
agedose
adults and children 12 years and over4 teaspoons every 4 hours
children 6 to 12 years2 teaspoons every 4 hours
children under 6 yearsdo not use

OTHER INFORMATION

  • each teaspoon contains: sodium 2 mg
  • store at 20-25°C (68-77°F)
  • dosage cup provided

INACTIVE INGREDIENTS

anhydrous citric acid, artificial flavor, FD&C red no. 40, glycerin, menthol, polyethylene glycol, propyl gallate, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

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.

SEE NEW WARNINGS INFORMATION

Children’s Dimetapp Multi-Symptom Cold & Flu

Acetaminophen (Pain Reliever/Fever Reducer)

Chlorpheniramine Maleate (Antihistamine)

Dextromethorphan HBr (Cough Suppressant)

Phenylephrine HCl (Nasal Decongestant)

Relieves Nasal Symptoms

  • Stuffy Nose
  • Runny Nose
  • Sneezing

Plus Other Symptoms

  • Itchy, Watery Eyes
  • Cough
  • Fever, Headaches
  • Body Aches

4 FL OZ (118 mL)

alcohol-free ∙ red grape flavor

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

We pledge to you that Dimetapp products contain only high quality ingredients and meet strict standards of quality and safety. You can trust Dimetapp products for your family.

Dosage Cup Provided

PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org

Pfizer

Madison, NJ 07940 USA

© 2010 Pfizer Inc.

Packaged with Tamper-Evident bottle cap. Do Not Use if breakable ring is separated or missing.

PAA018215.jpg
CHILDRENS DIMETAPP MULTISYMPTOM COLD AND FLU 
acetaminophen, chlorpheniramine maleate, dextromethorphan hbr, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0031-2246
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
acetaminophen (acetaminophen) acetaminophen160 mg  in 5 mL
chlorpheniramine maleate (chlorpheniramine) chlorpheniramine maleate1 mg  in 5 mL
dextromethorphan hydrobromide (dextromethorphan) dextromethorphan hydrobromide5 mg  in 5 mL
phenylephrine hydrochloride (phenylephrine) phenylephrine hydrochloride2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
FD&C Red No. 40 
glycerin 
menthol 
polyethylene glycol 
propyl gallate 
propylene glycol 
water 
sodium benzoate 
sodium citrate 
sorbitol 
sucralose 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2246-121 in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/04/2010
Labeler - Richmond Division of Wyeth (829390827)
Establishment
NameAddressID/FEIBusiness Operations
Richmond Division of Wyeth829390827MANUFACTURE, ANALYSIS, LABEL, PACK

Revised: 12/2010
 
Richmond Division of Wyeth

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