CHILDRENS MUCUS RELIEF CHEST CONGESTION PLUS COUGH- dextromethorphan hbr, guaifenesin liquid

Childrens Mucus Relief Chest Congestion Plus Cough by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 5 mL)
Dextromethorphan HBr                  5mg
Guaifenesin                              100 mg

PURPOSE

Purpose
Dextromethorphan HBr ...................... Cough suppressant
Guaifenesin....................................... Expectorant

INDICATIONS & USAGE

WARNINGS

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 DOCTOR

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

When using this product do not use more than directed

STOP USE

Stop use and ask adoctor 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.

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.

DOSAGE & ADMINISTRATION

Directions

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

• mL = milliliter

• Children 6 years to under 12 years:

  5 mL - 10 mL

  every 4 hours

• Children under 6 years: Do not use

OTHER SAFETY INFORMATION

Other information
each 5mL contains: sodium 3mg
store between 20-25°C (68-77°F)
do not refrigerate
dosing cup provided

INACTIVE INGREDIENT

Inactive ingredients
Anhydrous citric acid, flavors, purified water, sodium benzoate, sucrose

QUESTIONS

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

Principal Display Panel

CVS
HealthTM

Compare to the
active ingredients in
Children's Mucinex® Cough*

Children's
Mucus Relief
Chest Congestion
Plus Cough

Free of alcohol, dyes &
artificial sweeteners

DEXTROMETHORPHAN HBr
Cough suppressant

GUAIFENESIN
Expectorant

Relieves:
Chest congestion & cough
Thins & loosens mucus

Cherry Flavor

For Ages
6 to 12 Years

8 FL OZ (237 mL)

DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences

DO NOT REFRIGERATE. STORE AT ROOM TEMPERATURE.

*This product is not manufactured or distributed by Reckitt
Benckiser, distributor of Children's Mucinex® Cough.

Lot:
Exp:

LR-113 REV 01 #338883

0 50428 61752 6

DRUG FACTS→
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Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
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↓Product Package↓

Children's Mucus Relief Chest Congestion Plus Cough by CVS Pharmacy, Inc.

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INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF CHEST CONGESTION PLUS COUGH 
dextromethorphan hbr, guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-314
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)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76281-314-26	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2018

Labeler - AptaPharma Inc. (790523323)

Registrant - AptaPharma Inc. (790523323)

Establishment
Name	Address	ID/FEI	Business Operations
AptaPharma Inc.		790523323	manufacture(76281-314)