CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hydrobromide, guaifenesin liquid

Childrens Mucus Relief COUGH by

Drug Labeling and Warnings

Childrens Mucus Relief COUGH by is a Otc medication manufactured, distributed, or labeled by Chain Drug Consortium, LLC, AptaPharma Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Drug Facts

Active ingredients (in each 5 mL teaspoonful)

Dextromethorphan HBr 5 mg
Guaifenesin 100 mg

Purpose

Cough suppressant
Expectorant

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.

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps to 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 two weeks after stopping the MAOI drug. If you do not know if your child’s prescription drug contains an MAOI, ask a doctor or a pharmacist before taking this product.

Ask a doctor before use if the child has

• cough that occurs with too much phlegm (mucus)
• persistent 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 persistent headache.
  
• These could be signs of a serious condition.

Directions

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

Other information

    each teaspoon contains: sodium 3 mg

• store between 20-25 ° C (68-77° F)
• do not refrigerate
• dosage cup provided
• Keep carton for full directions for use

Inactive ingredients

citric acid anhydrous, dextrose, D and C Red # 33, FD and 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

Product Label

NDC: 68016-158-04
*COMPARE TO THE ACTIVE INGREDIENTS IN CHILDRENS MUCINEX® COUGH

Premier Value®

Childrens
Mucus Relief
COUGH

Dextromethorphan HBr ..... Cough Suppressant
Guaifenesin ..................... Expectorant


Relieves Chest Congestion
Thins and Loosens Mucus

Alcohol Free
For Ages 4 to 12

Cherry Flavor

 4 FL OZ (118mL)

INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
 

*This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® Cough

If for Any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

DISTRIBUTED BY
CHAIN DRUG CONSORTIUM
3301 NW BOCA RATON BLVD
SUITE 101, BOCA RATON, FL 33431


BX-015

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF COUGH 
dextromethorphan hydrobromide, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68016-158
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 (Cherry Flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68016-158-04	118 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	09/01/2012

Labeler - Chain Drug Consortium, LLC (101668460)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(68016-158)