CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hydrobromide and guaifenesin 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 CARDINAL HEALTH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• Active ingredients (in each 5 mL):

  Purpose

• 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.

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

Questions or comments?

1-866-467-2748

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

LEADER™

NDC: 70000-0131-1

Children's Mucus and Cough Relief

Dextromethorphan HBr , 5 mg

Guaifenesin, 100 mg

Cherry
Flavor

AGES 4-12 YEARS

Controls Cough
Relieves Chest Congestion
Breaks up Mucus

COMPARE TO CHILDREN’S MUCINEX® COUGH active ingredients

100% Money Back Guarantee

Dosing Cup included

4 FL OZ
(118 mL)

•   © CARDINAL HEALTH, the Cardinal Health LOGO, LEADER, and the Leader LOGO are trademarks or registered trademarks of Cardinal Health.

*This product is not manufactured or distributed by Reckitt Benckiser, owner of the registered trademark Children’s Mucinex® Cough.

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

•   CARDINAL HEALTH®

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com

1-800-200-6313

Essential to Care™ since 1979

All Leader Brand Products have a 100% Money Back Guarantee

Return to place of purchase if not satisfied

INGREDIENTS AND APPEARANCE

CHILDRENS MUCUS AND COUGH RELIEF 
dextromethorphan hydrobromide and guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0131
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 SODIUM (UNII: MP1J8420LU)
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: 70000-0131-1	1 in 1 CARTON	05/05/2017
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	05/05/2017

Labeler - CARDINAL HEALTH (097537435)