Label: CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin liquid
- NDC Code(s): 0031-8715-10
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- Category: HUMAN OTC DRUG LABEL
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 December 28, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each 5 ml)
- Purposes
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use if you are now 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 prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
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- cough that occurs with too much phlegm (mucus)
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- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema
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DOSAGE & ADMINISTRATION
Directions
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- measure only with dosing cup provided
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- keep dosing cup with product
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- ml = milliliter
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- do not take more than 6 doses in any 24-hour period
age dose children under 4 years
do not use
children 4 to under 6 years
5 ml every 4 hours
children 6 to under 12 years
10 ml every 4 hours
adults and children 12 years and over
20 ml every 4 hours
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS ROBITUSSIN COUGH AND CHEST CONGESTION DM
dextromethorphan hydrobromide, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8715 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL, (R)- (UNII: 602HN5L69H) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color PURPLE (purple) Score Shape Size Flavor GRAPE (grape) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8715-10 1 in 1 CARTON 07/01/2014 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/2014 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)