Label: CHILDRENS COUGH- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 49035-773-03
- Packager: Wal-Mart Stores, 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 November 28, 2022
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENTS (in each 5 mL)
- PURPOSE
-
USE(S)
- 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 YOU HAVE
- STOP USE AND A ASK 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 Dose children 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?
-
PRINCIPAL DISPLAY PANEL
NDC 49035-773-03
equate
Compare to Children's Mucinex® Cough active ingredients*
children's
COUGH LIQUID
Dextromethorphan HBr 5mg
Cough SuppressantGuaifenesin 100 mg
Expectorant
AGES 4 TO 12 YEARS
- Controls cough
- Thins and Loosens Mucus
- Relieves chest congestion
- Non-Drowsy
- Alcohol Free
Cherry Flavored
4 FL OZ (118 mL)
-
INGREDIENTS AND APPEARANCE
CHILDRENS COUGH
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-773 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:49035-773-03 1 in 1 CARTON 08/01/2017 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 08/01/2017 Labeler - Wal-Mart Stores, Inc. (051957769) Establishment Name Address ID/FEI Business Operations Guardian Drug Company 119210276 MANUFACTURE(49035-773)