CHILDRENS DIBROMM COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl liquid 
QUALITY CHOICE (Chain Drug Marketing Association)

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.

----------

Drug Facts

Active ingredients (in each 5 mL, 1 teaspoon)

Brompheniramine maleate 1 mg

Phenylephrine HCl 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):
    • 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
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

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

When using this product

  • do not use more than directed
  • may cause marked drowsiness
  • 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 occur
  • 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 (1-800-222-1222) right away.

Directions

  • do not take more than 6 doses in any 24-hour period 
  • measure only with dosing cup provided
  • keep dosing cup with product
  • tsp=teaspoon, mL=milliliter
 age dose
adults and children 12 years and over4 tsp (20 mL) every 4 hours
 children 6 to 11 years 2 tsp (10 mL) every 4 hours
 children under 6 yearsdo not use

Other information

  • each 5 mL contains: sodium 3 mg
  • store at 20°-25°C (68°-77°F). Do not refrigerate. 

Inactive ingredients

citric acid, FD&C blue #1, FD&C red # 40, glycerin, natural & artificial flavor, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol, sucralose

Principal Display Panel

*Compare to the active ingredients in Children's Dimetapp® Cold & Allergy

Children's Dibromm

Cold & Allergy

Brompheniramine Maleate

Antihistamine

Phenylephrine HCl

Nasal Decongestant

For Ages 6 & Over

Alcohol Free

Grape Flavor

FL OZ (mL)

*This product is not manufactured or distributed by Pfizer Consumer Healthcare, distributors of Children's Dimetapp® Cold & Allergy.

TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL ON THE BOTTLE OR UNDER THE CAP IS BROKEN OR MISSING.

Distributed by C.D.M.A., Inc.©

43157 W. Nine Mile

Novi, mi 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

Package Label

Bromopheniramine maleate 1 mg, Phenylephrine HCl 2.5 mg

Quality Choice Children's Dibromm Cold & Allergy

CHILDRENS DIBROMM COLD AND ALLERGY 
brompheniramine maleate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-246
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
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 (UNII: 1Q73Q2JULR)  
SORBITOL (UNII: 506T60A25R)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-246-081 in 1 BOX06/30/201406/30/2020
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:63868-246-041 in 1 BOX06/30/201406/30/2020
2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/201406/30/2020
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 6/2019
Document Id: bdbfa0b2-f3f9-4e6d-a049-baff262f4083
Set id: 60790cf2-6d75-4653-8fe5-a074f0fe6782
Version: 4
Effective Time: 20190625
 
QUALITY CHOICE (Chain Drug Marketing Association)