Skip to Content

← See all Childrens Cold and Cough brands

Childrens Cold and Cough by Care One (American Sales Company)

Medically reviewed on December 11, 2017

Dosage form: solution
Ingredients: BROMPHENIRAMINE MALEATE 2mg in 10mL, DEXTROMETHORPHAN HYDROBROMIDE 10mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL
Labeler: Care One (American Sales Company)
NDC Code: 41520-613

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

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Purpose

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 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
  • marked 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 occurs
  • symptoms do not improve with 7 days or are accompanied by fever
  • 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 a 24-hour period 
  • measure only with dosing cup provided. Do not use any other dosing device.
  • keep dosing cup with product
  • 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 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

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

Principal Display Panel

Children's Cold & Cough

Brompheniramine Maleate - Antihistamine

Dextromethorphan HBr - Cough Suppressant

Phenylephrine HCl - Nasal Decongestant

Compare to the Active Ingredients of CHILDREN'S DIMETAPP® COLD & COUGH*

  • Runny nose
  • Stuffy nose
  • Itchy nose or throat
  • Itchy, watery eyes
  • Sneezing, coughing

For ages 6 & over

Grape Flavor

Alcohol Free 

FL OZ (mL)

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

PARENTS: Learn about teen medicine abuse   www.StopMedicineAbuse.org

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

Package Label

Chidren's cold and cough

 

CHILDRENS COLD AND COUGH 
brompheniramine maleate, dextromethorphan hbr, phenylephrine hcl solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-613
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BROMPHENIRAMINE MALEATE (BROMPHENIRAMINE) BROMPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GLYCERIN 
PROPYLENE GLYCOL 
WATER 
SODIUM BENZOATE 
TRISODIUM CITRATE DIHYDRATE 
SORBITOL 
SUCRALOSE 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-613-041 BOTTLE, PLASTIC in 1 BOX
1118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34112/10/2015
Labeler - Care One (American Sales Company) (809183973)
Registrant - P & L Development, LLC (800014821)

 
Care One (American Sales Company)

← See all Childrens Cold and Cough 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.

Hide