CHILDRENS DIBROMM COLD AND ALLERGY- brompheniramine maleate, phenylephrine hcl liquid

Childrens Dibromm Cold and Allergy by

Drug Labeling and Warnings

Childrens Dibromm Cold and Allergy by is a Otc medication manufactured, distributed, or labeled by QUALITY CHOICE (Chain Drug Marketing Association). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 over: 4 tsp (20 mL) every 4 hours
• children 6 to 11 years: 2 tsp (10 mL) every 4 hours
• children under 6 years: do 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

Quality Choice Children's Dibromm Cold & Allergy

INGREDIENTS AND APPEARANCE

CHILDRENS DIBROMM COLD AND ALLERGY 
brompheniramine maleate, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-246
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BROMPHENIRAMINE MALEATE (UNII: IXA7C9ZN03) (BROMPHENIRAMINE - UNII:H57G17P2FN)	BROMPHENIRAMINE MALEATE	1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-246-08	1 in 1 BOX	06/30/2014	06/30/2020
1		237 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 63868-246-04	1 in 1 BOX	06/30/2014	06/30/2020
2		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	06/30/2014	06/30/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)