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
- 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 March 22, 2023
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- 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 FINAL part341 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)
