Label: CVS CHILDRENS COUGH RELIEF- dextromethorphan hydrobromide and guaifenesin liquid
- NDC Code(s): 69842-577-04
- Packager: CVS PHARMACY, INC
- 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.
Drug Label Information
Updated September 14, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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Uses
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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- temporarily relieves:
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- cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
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- the intensity of coughing
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- the impulse to cough to help your child get to sleep
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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
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- cough that occurs with too much phlegm (mucus)
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- persistent or chronic cough such as occurs with asthma
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Directions
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- do not take more than 6 doses in any 24-hour period
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- measure only with dosing cup provided
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- do not use dosing cup with other products
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- dose as follows or as directed by a doctor
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
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
Compare to the Active Ingredients in Children’s Mucinex® cough
NDC 69842-577-04
Children's Cough Relief
Dextromethorphan HBr , 5 mg
Guaifenesin,100 mg
Natural Cherry Flavor
Dosage Cup Included
Ages 4 + years
Controls Cough
Relieves Chest Congestion
Breaks up Mucus4 FL OZ(118 mL)
*This product is not manufactured or distributed by RB Health (USA), distributor of Children’s Mucinex® Cough.
IMPORTANT: Keep this carton for future reference on full labeling.
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INGREDIENTS AND APPEARANCE
CVS CHILDRENS COUGH RELIEF
dextromethorphan hydrobromide and guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-577 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:69842-577-04 1 in 1 CARTON 03/14/2022 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 03/14/2022 Labeler - CVS PHARMACY, INC (062312574)