CHILDRENS MUCUS AND COUGH RELIEF- guaifenesin and dextromethorphan hydrobromide liquid

Childrens Mucus and Cough Relief by

Drug Labeling and Warnings

Childrens Mucus and Cough 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

• Active ingredients (in each 5 mL):

  Purposes

• Dextromethorphan HBr 5 mg:

  Cough suppressant

• Guaifenesin 100 mg:

  Expectorant

Uses

• ▪ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• ▪ temporarily relieves:
  • ▪ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
  • ▪ the intensity of coughing
  • ▪ the impulse to cough to help your child get to sleep

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)
• ▪ 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 at 1-800-222-1222.

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 Red#40, flavors, potassium citrate, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

NDC: 63868-771-04

Compare to the Active ingredient in Children’s Mucinex Cough*

Children's

Mucus &Cough Relief

Cough Suppressant

Expectorant

Dextromethorphan HBr

Guaifenesin

Each Dose of Cherry Flavored

Children's

Mucus & Cough Relief:

Controls Cough
Relieves Chest Congestion
Breaks up Mucus

Alcohol-free

See New Dosing information

Cherry
Flavor

4 FL OZ
(118 mL)

IMPORTANT: Keep this carton for future reference on full labeling.

DOSAGE CUP INCLUDED

Distributed by C.D.M.A., Inc©

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questions: 248-449-9300

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

QC 100% Satisfaction Guaranteed.

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS AND COUGH RELIEF 
guaifenesin and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-771
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
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	RED	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-771-04	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)