Label: MUCUS RELIEF COUGH CHILDRENS- dextromethorphan hbr, guaifensin liquid
- NDC Code(s): 55319-294-04
- Packager: Family Dollar (FAMILY WELLNESS)
- 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 January 20, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 5 mL)
- Purposes
-
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
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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 taking 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
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Directions
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- keep dosing cup with product
- mL = milliliter
- shake well before using
age dose children 6 to 12 years 5-10 mL every 4 hours children 4 to 5 years 2.5-5 mL every 4 hours children under 4 years do not use
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
COMPARE TO THE ACTIVE INGREDIENTS IN CHILDREN'S MUCINEX® COUGH*
FOR AGES 4 TO 11 YEARS
Children's
Mucus Relief Cough
Dextromethorphan HBr - Cough Suppressant
Guaifenesin - Expectorant
Alcohol free
Dosing Cup Included
CHERRY FLAVOR
FL OZ (mL)
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Children's Mucinex® Cough.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: MIDWOOD BRANDS, LLC
10611 MONROE RD., MATTHEWS, NC 28105
- Package Label
-
INGREDIENTS AND APPEARANCE
MUCUS RELIEF COUGH CHILDRENS
dextromethorphan hbr, guaifensin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55319-294 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) D&C RED NO. 33 (UNII: 9DBA0SBB0L) DEXTROSE (UNII: IY9XDZ35W2) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM HYDROXIDE (UNII: 55X04QC32I) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55319-294-04 1 in 1 BOX 02/29/2016 02/28/2025 1 118 mL in 1 BOTTLE, PLASTIC; 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 02/29/2016 02/28/2025 Labeler - Family Dollar (FAMILY WELLNESS) (024472631)