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Childrens Dibromm Cold and Cough

Medically reviewed on Oct 26, 2017

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 1mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL, DEXTROMETHORPHAN HYDROBROMIDE 5mg in 5mL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
NDC Code: 63868-247

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

Dextromethorphan HBr 5 mg

Phenylephrine HCl 2.5 mg

Purposes

Antihistamine

Cough suppressant

Nasal decongestant

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation occurring with a cold, and 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
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or persistent or chronic cough that lasts such as occurs with smoking, asthma, chronic bronchitis, or emphysema 

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
  • 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
  • new symptoms occur
  • nervousness, dizziness or sleeplessness occur
  • fever gets worse or lasts more than 3 days
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

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 & Cough

Children's Dibromm

Cold & Cough

Brompheniramine Maleate

Antihistamine

Dextromethorphan HBr

Cough Suppressant

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 & Cough.

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 and Cough

CHILDRENS DIBROMM COLD AND COUGH 
brompheniramine maleate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-247
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE1 mg  in 5 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:63868-247-041 BOTTLE in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/30/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

 
QUALITY CHOICE (Chain Drug Marketing Association)

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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