CHILDRENS MUCUS RELIEF CHEST CONGESTION- guaifenesin liquid

Childrens Mucus Relief Chest Congestion by

Drug Labeling and Warnings

Childrens Mucus Relief Chest Congestion 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 ingredient (in each 5 mL)
Guaifenesin, USP                           100 mg

PURPOSE

Purpose
Guaifenesin, USP ......................................... Expectorant

INDICATIONS & USAGE

Uses Helps loosen phlegm (mucus) and thin bronchial secretions
to rid the bronchial passageways of bothersome mucus and make
coughs more productive

WARNINGS

Warnings
Ask a doctor before use if the child has
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with asthma

WHEN USING

When using this product
do not use more than directed

STOP USE

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.

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

INACTIVE INGREDIENT

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

QUESTIONS

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

Principal Display Package

CVS
HealthTM

Compare to the active
ingredient in Children's
Mucinex® Chest Congestion*

Children's
Mucus Relief
Chest
Congestion

Free of alcohol, dyes &
artificial sweeteners

GUAIFENESIN ORAL SOLUTION, USP
Expectorant

Relieves:
Chest congestion

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®
Chest Congestion.

Lot:
Exp:

LR-114 REV 01 #338983

0 50428 61657 4

CONTINUED →
ON BACK

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2018 CVS/pharmacy
CVS.com® 1-800-SHOP CVS
V-34690

√CVS Quality
Money Back Guarantee

↓Product Package↓

                               Children's Mucus Relief, by CVS Pharmacy, Inc.

res

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF CHEST CONGESTION 
guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76281-318
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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: 76281-318-26	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(76281-318)