CHILDRENS DIMETAPP COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl tablet, chewable 
Richmond Division of Wyeth

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.

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CHILDREN'S DIMETAPP COLD & ALLERGY CHEWABLE TABLETS
(brompheniramine maleate and phenylephrine HCl)

DRUG FACTS

ACTIVE INGREDIENTS (IN EACH TABLET)

Brompheniramine maleate, USP 1 mg

Phenylephrine HCl, USP 2.5 mg

PURPOSES

Antihistamine

Nasal decongestant

USES

  • temporarily relieves nasal congestion due to the common cold, hay fever or other upper respiratory allergies
  • temporarily relieves these symptoms due to hay fever (allergic rhinitis) or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily restores freer breathing through the nose

WARNINGS

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.

Ask a doctor before use if you have

  • 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 any other oral nasal decongestant or stimulant
  • taking sedatives or tranquilizers

When using this product

  • do not use more than directed
  • drowsiness may occur
  • avoid alcoholic beverages
  • 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
  • symptoms do not get better within 7 days or are accompanied by fever

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.

DIRECTIONS

  • do not take more than 6 doses in any 24-hour period
agedose
adults and children 12 years and over4 tablets every 4 hours
children 6 to under 12 years2 tablets every 4 hours
children under 6 yearsdo not use

OTHER INFORMATION

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

carmine, carrageenan, croscarmellose sodium, fructose, fumaric acid, glycine, magnesium stearate, maltodextrin, mannitol, microcrystalline cellulose, modified starch, natural and artificial flavor, polyethylene oxide, silicon dioxide, sorbitol, sucralose, tribasic calcium phosphate

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 WARNING INFORMATION

Children's Dimetapp Cold & Allergy

BROMPHENIRAMINE MALEATE (Antihistamine)

PHENYLEPHRINE HCI (Nasal Decongestant)

Relieves Nasal Symptoms

  • Stuffy Nose
  • Runny Nose
  • Sneezing

Plus Other Symptoms

  • Itchy, Watery Eyes

For Ages 6 Yrs. & Over

20 chewable tablets

grape flavor

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

Wyeth Consumer Healthcare Madison, NJ 07940 USA ©2009 Wyeth

Made in Canada

TABLETS INDIVIDUALLY BLISTER SEALED. IF SEAL IS BROKEN, DO NOT USE.

Children's Dimetapp Cold & Allergy Chewable Tablets Packaging
CHILDRENS DIMETAPP COLD AND ALLERGY 
brompheniramine maleate, phenylephrine hcl tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2293
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg
Inactive Ingredients
Ingredient NameStrength
COCHINEAL (UNII: TZ8Z31B35M)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
FRUCTOSE (UNII: 6YSS42VSEV)  
FUMARIC ACID (UNII: 88XHZ13131)  
GLYCINE (UNII: TE7660XO1C)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MANNITOL (UNII: 3OWL53L36A)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
Product Characteristics
ColorPURPLE (mottled, purple-colored chewable tablet) Score2 pieces
ShapeROUNDSize9mm
FlavorGRAPEImprint Code DTP
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2293-212 in 1 CARTON09/27/200506/30/2012
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/27/200506/30/2012
Labeler - Richmond Division of Wyeth (829390835)
Establishment
NameAddressID/FEIBusiness Operations
Pfizer Canada Inc.246770197ANALYSIS(0031-2293) , LABEL(0031-2293) , MANUFACTURE(0031-2293) , PACK(0031-2293)

Revised: 8/2017
 
Richmond Division of Wyeth