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Childrens Dibromm Cold and Allergy

Medically reviewed on June 25, 2018

Dosage form: liquid
Ingredients: BROMPHENIRAMINE MALEATE 2mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL
Labeler: Select Brand Dist.
NDC Code: 15127-012

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 10 mL)

Brompheniramine maleate 2 mg

Phenylephrine HCI 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
    • itchy, watery eyes
    • sneezing
    • 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
  • glaucoma
  • diabetes
  • thyroid disease
  • 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 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 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. Do not use any other dosing device.
  • keep dosing cup with product
  • shake well before using
  • mL = milliliter
 age dose
adults and children 12 years and over20 mL every 4 hours
 children 6 to 11 years 10 mL every 4 hours
 children under 6 yearsdo not use

Other information
  • each 10 mL contains:sodium 5 mg
  • store between 20-25°C (68-77°F). Do not refrigerate. 

Inactive ingredients

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

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST 

Principal Display Panel

Children's

Dibromm

Cold & Allergy

Brompheniramine Maleate  Antihistamine

Phenylephrine HCI  Nasal Decongestant

*Compare ti the active ingredients in CHILDREN'S DIMETAPP® COLD & ALLERGY

  • Itchy, watery eyes
  • Runny nose
  • Sneezing
  • Itchy of the nose or throat

For Ages 6 and 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 CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND  BOTTLE OR UNDER CAP IS BROKEN OR MISSING.

Dosage Cup Provided

Distributed by:

Select Brand® Distributors

Pine Bluff, AR 71603 USA

AC (870)535-3635

Package Label

Select Brand Children's Dibromm Cold & Allergy

CHILDRENS DIBROMM  COLD AND ALLERGY
brompheniramine maleate, phenylephrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15127-012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
SUCRALOSE 
ANHYDROUS CITRIC ACID 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:15127-012-041 BOTTLE in 1 BOX
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/2015
Labeler - Select Brand Dist. (012578514)

 
Select Brand Dist.

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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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