Label: ROBITUSSIN COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin solution
- NDC Code(s): 0031-8757-12, 0031-8757-18
- 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.
Updated January 20, 2023
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- Active ingredients (in each 20 ml)
- INDICATIONS & USAGE
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
- cough that occurs with too much phlegm (mucus)
- cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
DOSAGE & ADMINISTRATION
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided
- keep dosing cup with product
- ml = milliliter
- this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over
20 ml every 4 hours
children under 12 years
do not use
- STORAGE AND HANDLING
anhydrous citric acid, carboxymethylcellulose sodium, FD&C blue no. 1, FD&C red no. 40, glycerin, liquid glucose, menthol, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, triacetin, xanthan gum
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 237 ml Bottle Carton
INGREDIENTS AND APPEARANCE
ROBITUSSIN COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8757 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SODIUM GLUCONATE (UNII: R6Q3791S76) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIACETIN (UNII: XHX3C3X673) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8757-12 1 in 1 CARTON 06/01/2018 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:0031-8757-18 1 in 1 CARTON 06/01/2018 2 237 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 06/01/2018 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0031-8757) , LABEL(0031-8757) , MANUFACTURE(0031-8757) , PACK(0031-8757)