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: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 19, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 ml)
- Purposes
- Uses
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Warnings
Do not useif 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
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Directions
- 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
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
- Relieves Chest Congestion
- 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 Drug M012 06/01/2016 Labeler - Haleon US Holdings LLC (079944263) Establishment Name Address ID/FEI Business Operations Pf Soins De Sante Sri 203812479 analysis(0031-8739) , label(0031-8739) , manufacture(0031-8739) , pack(0031-8739)