Label: ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 0031-2097-01, 0031-2097-02
- 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 May 25, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- 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, 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
Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
For most recent product information, visit www.robitussin.com
Trademarks owned or licensed by GSK
@2021 GSK or licensor
Should be 18 or older to purchase
Learn about teen medicine abuse
Packaged with Tamper-Evident bottle cap.
Do Not Use if breakable ring is separated or missing.
PRINCIPAL DISPLAY PANEL
DEXTROMETHORPHAN HBr (Cough Suppressant)
- Controls Cough
- Relieves Chest Congestion
- Thins & Loosens Mucus
For Ages 12+
8 FL OZ (237 ml)
PAA163287 Front Carton
INGREDIENTS AND APPEARANCE
ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hbr, guaifenesin solution
Product 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 FORM (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 final part341 06/14/2021 Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)