COUGH RELIEF- dextromethorphan hbr liquid

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

age	dose
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 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

Care One Cough Relief Liquid

INGREDIENTS AND APPEARANCE

COUGH RELIEF
dextromethorphan hbr liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg in 5 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 41520-308-04	1 in 1 BOX	07/31/2015	07/31/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	07/31/2015	07/31/2020

Labeler - Care One (American Sales Company) (809183973)

Cough Relief by