Label: CHILDRENS MUCUS AND COUGH RELIEF- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 70000-0630-1
- Packager: CARDINAL HEALTH 110, LLC. DBA LEADER
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 16, 2024
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)
- PURPOSE
-
USES
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make coughs more productive
- temporarily relieves:
- cough due to minor throat and bronchial irritation as may occur with a cold or inhaled irritants
- the impulse to cough to help your child get to sleep
- the intensity of coughing
- WARNING
-
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
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN
-
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
Dosechildren 6 years to under 12 years 5 mL-10 mL
every 4 hourschildren 4 years to under 6 years 2.5 mL - 5 mL
every 4 hourschildren under 4 years do not use
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS COMMENTS?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CHILDRENS MUCUS AND COUGH RELIEF
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0630 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) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) D&C RED NO. 33 (UNII: 9DBA0SBB0L) 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) SORBITOL (UNII: 506T60A25R) SODIUM HYDROXIDE (UNII: 55X04QC32I) 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:70000-0630-1 1 in 1 CARTON 03/22/2023 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 Drug M012 03/22/2023 Labeler - CARDINAL HEALTH 110, LLC. DBA LEADER (063997360) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(70000-0630)
