Childrens mucus and cough relief liquid

Spl unclassified section

Drug Facts

Otc - active ingredient section

Otc - purpose section

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

Otc - do not use section

Do not usein 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.

Otc - ask doctor section

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

Otc - stop use section

Stop use and ask a doctor ifcough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

Otc - keep out of reach of children section

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

Ingredients and appearance - Product information

Childrens mucus and cough relief liquid- Dextromethorphan hydrobromide and guaifenesin

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 70000-0131
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Dextromethorphan hydrobromide ( UNII: 9D2RTI9KYH)( Dextromethorphan - UNII: 7355X3ROTS ) 5 mgin 5 mL
Guaifenesin ( UNII: 495W7451VQ)( Guaifenesin - UNII: 495W7451VQ ) 100 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
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 Flavor CHERRY

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
OTC monograph final part341 USA

Labeler - CARDINAL HEALTH( 097537435)

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 CHILDRENS 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 Childrens 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