Label: ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide, guaifenesin solution
- NDC Code(s): 0031-8739-12, 0031-8739-18, 0031-8739-42
- Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
- 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 February 1, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 ml)
- Purposes
- Uses
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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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Directions
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- do not take more than 6 doses in any 24-hour period
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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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- this adult product is not intended for use in children under 12 years of age
age dose adults and children 12 years and over
20 ml every 4 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
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Principal Display Panel
See
New
DosingADULT
Robitussin®MAXIMUM STRENGTH
Cough+Chest
Congestion DMDEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)- •
- Controls Cough
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- Relieves Chest Congestion
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- Thins & Loosens Mucus
Non-Drowsy
BETTER
TASTING!
Same Effective
Cough Relief*DM
MAXFor Ages 12 & Over
4 FL OZ (118 ml)
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INGREDIENTS AND APPEARANCE
ROBITUSSIN MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-8739 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 400 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) SUCRALOSE (UNII: 96K6UQ3ZD4) TRIACETIN (UNII: XHX3C3X673) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-8739-12 1 in 1 CARTON 06/01/2016 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:0031-8739-18 1 in 1 CARTON 06/01/2016 2 237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 3 NDC:0031-8739-42 1 in 1 CARTON 06/01/2016 3 355 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 06/01/2016 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263) Establishment Name Address ID/FEI Business Operations PF Consumer Healthcare Canada ULC 203812479 ANALYSIS(0031-8739) , LABEL(0031-8739) , MANUFACTURE(0031-8739) , PACK(0031-8739)