COUGH RELIEF- dextromethorphan hbr liquid 
Care One (American Sales Company)

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.

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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 impulse 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

When using this product,

do not use more than directed

Stop use and ask a doctor if

cough lasts more than 7 days, comes back, or is accompanied by fever, rash or persistent headache that lasts. 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

  • 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
  • shake well before using
  • mL=milliliter
age dose 
 adults and children 12 years and over10 mL every 6-8 hours not to exceed 4 doses in 24 hours, 
children 6 to 11 years of age5 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 3 mg 
  • store at 20º-25ºC (68º-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

Principal Display Panel

For ages 6 and over

Cough Relief

Dextromethorphan HBr 15 mg

Cough suppressant

6-8 hour relief

Grape flavor

Alcohol free

FL OZ (mL)

Contains no fever reducer or pain reliever

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

DISTRIBUTED BY

FOODHOLD USA, LLC

LANDOVER, MD 20785

1-877-846-9949

Dosing Cup Included

Package Label

Dextromethorphan HBr 15 mg

Care One Cough Relief Liquid

COUGH RELIEF 
dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-308
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)  
HYDROXYETHYL CELLULOSE (1500 MPA.S AT 1%) (UNII: L605B5892V)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
SUCROSE (UNII: C151H8M554)  
XANTHAN GUM (UNII: TTV12P4NEE)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41520-308-041 in 1 BOX07/31/201507/31/2020
1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/31/201507/31/2020
Labeler - Care One (American Sales Company) (809183973)

Revised: 7/2019
 
Care One (American Sales Company)