ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hbr, guaifenesin solution 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

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Drug Facts

Active ingredients (in each 20 ml)

Dextromethorphan HBr, USP 20 mg

Guaifenesin, USP 400 mg

Purposes

Cough suppressant

Expectorant

Uses

temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes

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

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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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
agedose

adults and children

12 years and over

20 ml every 4 hours

children under 12 years

do not use

Other information

each 20 ml contains: potassium 5 mg,sodium 20 mg
store at 20-25°C (68-77°F). Do not refrigerate.

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 or comments?

call weekdays from 9 AM to 5 PM EST at 1-800-245-1040

Additional information

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

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

NDC 0031-2097-02

ADULT

NEW!

Robitussin

Elderberry

Cough+Chest
Congestion DM

DEXTROMETHORPHAN HBr (Cough Suppressant)
GUAIFENESIN (Expectorant)

NON-DROWSY

MAXIMUM STRENGTH

Controls Cough
Relieves Chest Congestion
Thins & Loosens Mucus

Taste the
Real Elderberry

DM
MAX

For Ages 12+
8 FL OZ (237 ml)

PAA163287 Front Carton

Robi MS Elderberry CCC 237 ml Front Carton
ROBITUSSIN ELDERBERRY MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM 
dextromethorphan hbr, guaifenesin solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0031-2097
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE20 mg  in 20 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN400 mg  in 20 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorPURPLE (dark-purple to dark purple-brown) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0031-2097-011 in 1 CARTON06/14/2021
1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
2NDC:0031-2097-021 in 1 CARTON06/14/2021
2237 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/14/2021
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 5/2021
Document Id: d13efbcd-1277-45d0-8389-1ba0337f7a24
Set id: d13efbcd-1277-45d0-8389-1ba0337f7a24
Version: 1
Effective Time: 20210525
 
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC