Label: CHILDRENS MUCUS RELIEF COUGH- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 30142-419-26
- Packager: Kroger Company
- 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 December 3, 2015
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- Active ingredients (in each 5 mL)
Dextromethorphan HBr 5 mg
Guaifenesin 100 mgClose
- 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 condition.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).
- 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
- do not use if printed neckband is broken or missing
- store at 20-25 °C (68-77 °F)
- do not refrigerate
- dosing cup provided
- Inactive ingredients
acesulfame potassium, anhydrous citric acid, D&C red #33, FD&C red #40, flavor, glycerin, maltitol solution, propylene glycol, purified water, saccharin sodium, sodium benzoate, sorbitol solution, xanthan gumClose
- Questions or comments?
- Principal Display Panel
COMPARE TO the active ingredients of CHILDREN’S MUCINEX® COUGH
See back panel
FOR AGES 4+
Guaifenesin 100 mg, Expectorant
Dextromethorphan HBr 5 mg, Cough Suppressant
4 FL OZ (118 mL)Close
- INGREDIENTS AND APPEARANCE
CHILDRENS MUCUS RELIEF COUGH
dextromethorphan hbr, guaifenesin solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-419 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 ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) XANTHAN GUM (UNII: TTV12P4NEE) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color RED (Dark Red) Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:30142-419-26 1 in 1 CARTON 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 09/26/2007 Labeler - Kroger Company (006999528)