Label: ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 0031-2097-01, 0031-2097-02
- Packager: Haleon US Holdings LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 16, 2024
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- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
- INDICATIONS & USAGE
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WARNINGS
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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DOSAGE & ADMINISTRATION
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
- STORAGE AND HANDLING
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INACTIVE INGREDIENT
Inactive ingredients
anhydrous citric acid, black elderberry juice concentrate (for flavor), carboxymethylcellulose sodium, glycerin, liquid glucose, maltodextrin, natural and artificial flavors, polyethylene glycol, propylene glycol, purified water, sodium benzoate, sodium citrate, sodium gluconate, sucralose, xanthan gum, zinc gluconate
- QUESTIONS
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Additional information
Distributed by: Haleon, Warren, NJ 07059
©2023 Haleon group of companies or its licensor.
Trademarks are owned by or licensed to the Haleon group of companies.
For most recent product information, visit www.robitussin.com
Pat. Info www.productpats.com
Made in Canada
PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org
Packaged with Tamper-Evident bottle cap.
Do Not Use if breakable ring is separated or missing.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0031-2097 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) GLYCERIN (UNII: PDC6A3C0OX) 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) XANTHAN GUM (UNII: TTV12P4NEE) ZINC GLUCONATE (UNII: U6WSN5SQ1Z) Product Characteristics Color purple (dark-purple to dark purple-brown) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0031-2097-01 1 in 1 CARTON 06/14/2021 1 118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package 2 NDC:0031-2097-02 1 in 1 CARTON 06/14/2021 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 Drug M012 06/14/2021 Labeler - Haleon US Holdings LLC (079944263)