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Childrens Cough Relief by Care One (American Sales Company)

Dosage form: liquid
Ingredients: DEXTROMETHORPHAN HYDROBROMIDE 15mg in 5mL
Labeler: Care One (American Sales Company)
NDC Code: 41520-454

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 ingredient (in each 5 mL)

Dextromethorphan HBr 15 mg

Purpose

Cough suppressant

Uses
  • temporarily relieves
    • cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
    • the impluse to cough to help you get to sleep

Warnings

Do not use
  • 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
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts as occurs with smoking, asthma or emphysema

Stop use and ask a doctor if

cough lasts more than 7 days, cough comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious condition.

When using this product,

do not use more than directed

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
  • take recommended dosage or as directed by a doctor
  • measure only with dosing cup provided Do not use any other dosing device.
  • keep dosing cup with product
  • mL = milliliter
  • shake well before using
agedose 
 adults and children 12 years and over 10 mL every 6-8 hours not to exceed 4 doses in 24 hours
 children 6 to 11 years of age 5 mL every 6-8 hours not to exceed 4 doses in 24 hours
 children under 6 years of age do not use

Other information
  • each 5 mL contains: sodium 2 mg
  • store at 20-25ºC (68-77ºF). Do not refrigerate.

Inactive ingredients

anhydrous citric acid, D&C red #33, disodium EDTA, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sucralose, sucrose, xanthan gum

Questions or comments?

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

Principal Display Panel

Children's Cough Relief

Cough Suppressant

Dextromethorphan HBr 15 mg

For Ages 6 & Over

6-8 Hour Relief

Alcohol Free

Grape Flavor

FL OZ (mL)

Contains no fever reducer or pain reliever.

See side panel for full dosing directions.

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

DISTRIBUTED BY

FOODHOLD USA, LLC

LANDOVER, MD 20785

Package Label

Care One Children's Cough Relief

CHILDRENS COUGH RELIEF 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-454
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
ANHYDROUS CITRIC ACID 
EDETATE DISODIUM 
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) 
GLYCERIN 
HIGH FRUCTOSE CORN SYRUP 
PROPYLENE GLYCOL 
WATER 
D&C RED NO. 33 
SODIUM BENZOATE 
SUCRALOSE 
SUCROSE 
XANTHAN GUM 
POLYETHYLENE GLYCOLS 
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41520-454-041 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 FINALpart34108/31/2015
Labeler - Care One (American Sales Company) (809183973)

 
Care One (American Sales Company)

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Medically reviewed on Sep 21, 2018

Further information

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

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