CHILDRENS COUGH MUCUS RELIEF- dextromethorphann hbr, guaifenesin liquid

Childrens Cough Mucus Relief by

Drug Labeling and Warnings

Childrens Cough Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Discount Drug Mart, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive ingredients(in each 5 mL teaspoonful)

Dextromethorphan HBr, USP 5 mg
Guaifenesin, USP 100 mg

Purpose

Cough suppressant
Expectorant

Uses

• temporarily relieves: cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to drain the bronchial tubes

Warnings

Do not use in a child who is 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 child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if the child has

• cough that occurs with too much phlegm (mucus)
• persistant or chronic cough such as occurs with asthma

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 occurs with fever, rash, or persistant  headache.

These could be signs of a serious condition.

Keep out of reach of children.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away

Directions

• do not take more than 6 doses in any 24-hour period

age                                                                   dose

Children 6 years to 12 years                               1 to 2 teaspoonfuls (tsps) every 4 hours
Children 4 years to under 6 years                        1/2 to 1 teaspoonful (tsps) every 4 hours
Children under 4 years                                         do not use

Other information

• each teaspoonful contains sodium 3 mg
• store between20-25°C (68-77°F)
• do not refrigerate
• dosing cup provided
• Keep carton for full direction for use

Inactive ingredients

anhydrous citric acid, dextrose, D&C red #33, FD&C red #40, flavors, glycerin, maltitol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sucralose, xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Children's Cough Mucus Relief product label

DISCOUNT
drug
mart
FOOD FAIR

DO NOT USE IF PRINTED SEAL, UNDER CAP IS TORN OR MISSING

COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*

Children's Cough Mucus Relief

Cough Suppressent

Expectorant

Dextromethorphan HBr 5 mg

Guaifensin 100 mg

Relieves Chest Congestion

Thins & Loosens Mucus

Alcohol free
for ages 4 to 12

CHERRY FLAVOR

4 FL OX (118 ml)

* this product is not manufactured or distributed by Reckitt Benckiser Inc., the distributer of Childrens Mucinex® Cough.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STOORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINA, OHIO 44256

BX-052

INGREDIENTS AND APPEARANCE

CHILDRENS COUGH MUCUS RELIEF 
dextromethorphann hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53943-512
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
DEXTROSE (UNII: IY9XDZ35W2)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53943-512-24	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/04/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/04/2016

Labeler - Discount Drug Mart (047741335)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(53943-512)