CHILDRENS MUCUS RELIEF CHEST CONGESTION- guaifenesin solution

Childrens Mucus Relief by

Drug Labeling and Warnings

Childrens Mucus Relief by is a Otc medication manufactured, distributed, or labeled by Chain Drug Manufacturing Assn. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each 5 mL)

Guaifenesin, USP 100 mg

Purpose

Expectorant

Uses

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

Warnings

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

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 illness.

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
• ▪ measure only with dosing cup provided
• ▪ do not use dosing cup with other products
• ▪ mL = milliliter

Age	Dose
children 6 years to under 12 years	5 mL – 10 mL every 4 hours
children 4 years to under 6 years	2.5 mL – 5 mL every 4 hours
children under 4 years	do not use

Other information

• ▪ each 5 mL contains: sodium 3 mg
• ▪ Tamper evident: do not use if printed inner seal under cap is torn or missing.
• ▪ store at room temperature
• ▪ do not refrigerate
• ▪ dosing cup provided

Inactive ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, potassium citrate propylene glycol, purified water, sodium benzoate ,sorbitol, sucralose, xanthan gum.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

QC QUALITY CHOICE NDC: 63868-770-04

Children's
Mucus relief

Expectorant

Guaifenesin

Oral Solution, USP

Each Dose of Grape Flavored

Children’s Mucus Relief:

Relieves Chest Congestion

•   Breaks up Mucus

Alcohol Free

•   See New Dosing Information

Grape
Flavor

4 FL OZ
(118 mL)

IMPORTANT:

Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

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

Distributed by C.D.M.A.,Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

QC 100% Satisfaction Guaranteed.

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS RELIEF  CHEST CONGESTION
guaifenesin solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-770
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C blue no. 1 (UNII: H3R47K3TBD)
FD&C red no. 40 (UNII: WZB9127XOA)
POTASSIUM CITRATE (UNII: EE90ONI6FF)
propylene glycol (UNII: 6DC9Q167V3)
water (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITOL (UNII: 506T60A25R)
sucralose (UNII: 96K6UQ3ZD4)
xanthan gum (UNII: TTV12P4NEE)

Product Characteristics
Color	PURPLE	Score
Shape		Size
Flavor	GRAPE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-770-04	1 in 1 CARTON	10/19/2015
1		118 mL in 1 BOTTLE; 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	10/19/2015

Labeler - Chain Drug Manufacturing Assn (011920774)