Label: CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hydrobromide and guaifenesin liquid
- NDC Code(s): 70000-0131-1
- Packager: CARDINAL HEALTH
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated July 27, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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
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.
- 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
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
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Children's Mucus and Cough Relief
Dextromethorphan HBr , 5 mg
Guaifenesin, 100 mg
AGES 4-12 YEARS
Relieves Chest Congestion
Breaks up Mucus
COMPARE TO CHILDREN’S MUCINEX® COUGH active ingredients
100% Money Back Guarantee
Dosing Cup included
4 FL OZ
- © 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
Essential to Care™ since 1979
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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 (063997360)