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Childrens Cold and Allergy by Chain Drug Consortium, LLC

Medically reviewed on December 22, 2017

Dosage form: solution
Ingredients: BROMPHENIRAMINE MALEATE 1mg in 5mL, PHENYLEPHRINE HYDROCHLORIDE 2.5mg in 5mL
Labeler: Chain Drug Consortium, LLC
NDC Code: 68016-127

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 tsp) dose )

Brompheniramine maleate, USP 1 mg
Phenylephrine HCl, USP 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
  • 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
  • you get nervous, dizzy, or sleepless
  • 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 dosage cup provided
  • keep dosage cup with product
  • do not use any other dosing device
  • tsp=teaspoon, mL = milliliter

Age
Dose
 adults and children 12 years and over
 20 mL (4 tsp) every 4 hours
 children 6 to under 12 years
 10 mL (2 tsp) every 4 hours
 children under 6 years
  do not use   

Other information

each 5 mL contains: sodium 2 mg

• store at 20-25oC (68-77oF)

• see bottom panel for lot number and expiration date

Inactive ingredients

Anhydrous citric acid, FD&C Blue No.1, FD&C Red No. 40, flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution, sucralose

Questions or comments?

1-855-274-4122

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

Distributed by:
Chain Drug Consortium, LLC
UPARC, Bldg. A3, Suite 338
1020 William Pitt Way
Pittsburgh, PA 15238
www.chaindrugconsortium.com
MADE IN USA

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 4 FL OZ (118 mL Bottle)

NDC 68016-127-04
*Compare to the active ingredients
in Children's Dimetapp®

Cold & Allergy

Premier Value®


Children's
Clod & Allergy

Brompheniramine Maleate, USP 1 mg –
Antihistamine
Phenylephrine HCl, USP 2.5 mg
Nasal Decongestant

Relieves Nasal Symptoms:

  • Stuffy Nose
  • Runny Nose
  • Sneezing

Plus Other Symptoms:

  • Itchy, Watery Eyes

 

For Ages
6 years
& Over

Grape Flavor

Dosage Cup Provided

Alcohol Free
4 FL OZ (118 mL)



CHILDRENS COLD AND ALLERGY 
brompheniramine maleate and phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-127
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
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GRAPE 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
SODIUM CITRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
ColorPURPLEScore    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:68016-127-041 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34106/03/2015
Labeler - Chain Drug Consortium, LLC (101668460)

 
Chain Drug Consortium, LLC

← See all Childrens Cold and Allergy brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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