CHILDRENS 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 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

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 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

INGREDIENTS AND APPEARANCE

CHILDRENS 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
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SUCROSE (UNII: C151H8M554)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)

#	Item Code	Package Description
Packaging
1	NDC: 41520-454-04	1 in 1 BOX
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	08/31/2015

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

Childrens Cough Relief by