DIMETAPP  COLD AND ALLERGY- brompheniramine maleate and phenylephrine hydrochloride elixir 
Foundation Consumer Brands

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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Dimetapp®
Cold and Allergy

Drug Facts

Active ingredients (in each 10 mL)Purposes
Brompheniramine maleate, 2 mgAntihistamine
Phenylephrine HCl, 5 mgNasal decongestant

Uses

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

  • nervousness, dizziness or sleeplessness occurs
  • 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

agedose
adults and children 12 years and over20 mL every 4 hours
children 6 to under 12 years10 mL every 4 hours
children under 6 yearsdo not use

Other information

Inactive ingredients

anhydrous citric acid, artificial flavor, FD&C blue no. 1, FD&C red no. 40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

Call 1-888-594-0828 weekdays 9 AM to 5 PM EST

Distributed by:
Foundation Consumer Brands, LLC
Pittsburgh, PA 15212

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

CHILDREN'S
Dimetapp®

BROMPHENIRAMINE MALEATE (Antihistamine)
PHENYLEPHRINE HCl (Nasal Decongestant)

PHARMACIST
RECOMMENDED

Cold &
Allergy

Relieves + comforts:

Stuffy, runny nose
Itchy, watery eyes
Sneezing

6+
YRS

4 FL OZ
(118 mL)

Grape Flavor • Alcohol Free

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
DIMETAPP   COLD AND ALLERGY
brompheniramine maleate and phenylephrine hydrochloride elixir
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80070-300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80070-300-041 in 1 CARTON09/15/2021
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:80070-300-081 in 1 CARTON09/15/2021
2237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34109/15/2021
Labeler - Foundation Consumer Brands (117603632)

Revised: 6/2023
Document Id: 75816e1a-090e-4fba-a41c-5bd924c62546
Set id: 47317865-4310-4f07-8815-f3130963307d
Version: 3
Effective Time: 20230607
 
Foundation Consumer Brands