COUGH RELIEF CHILDRENS- dextromethorphan hbr liquid

Cough Relief by

Drug Labeling and Warnings

Cough Relief by is a Otc medication manufactured, distributed, or labeled by TOP CARE (Topco Associates LLC). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• chronic cough that lasts as occurs with smoking, asthma, or emphysema
• cough that occurs with too much phlegm (mucus)

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

• 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 between 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 toll free 1-888-423-0139

Principal Display Panel

ORAL SOLUTION

Children's Cough Relief

Cough Suppressant

(Dextromethorphan HBr 15 mg)

• Alcohol free
• 6-8 Hour Relief
• For ages 6 & over

Grape Flavor

FL OZ (mL)

Dosing Cup Included

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 TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

©TOPCO AAR715

topcare@topco.com

www.topcarebrand.com

Package Label

TopCare Children's Cough Relief Grape

INGREDIENTS AND APPEARANCE

COUGH RELIEF  CHILDRENS
dextromethorphan hbr liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-454
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)

Product Characteristics
Color		Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-454-04	1 in 1 BOX	09/30/2015	09/30/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	09/30/2015	09/30/2020

Labeler - TOP CARE (Topco Associates LLC) (006935977)