MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM: Package Insert and Label Information

MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM- dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
WALGREENS

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 Facts

Active ingredients (in each softgel) Purposes
Dextromethorphan HBr, USP 10 mg Cough suppressant
Guaifenesin, USP 200 mg 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 12 softgels in any 24-hour period
  • this adult product is not intended for use in children under 12 years of age
age dose
adults and children 12 years and over 2 softgels every 4 hours
children under 12 years do not use

Other information

  • store at 20-25°C (68-77°F).
  • avoid excessive heat above 40°C (104°F).

Inactive ingredients

FD&C Red-40, gelatin, glycerin, polyethylene glycol 400, povidone K30, propylene glycol, purified water, special sorbitol, titanium dioxide

Questions or comments?

1-888-333-9792

DISTRIBUTED BY:
WALGREEN CO.
200 WILMOT ROAD
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL — 20 Softgel Blister Pack Carton

Walgreens

NDC 0363-0115-20

Compare to Robitussin® Maximum

Strength Cough+Chest Congestion

DM active ingredients‡‡


ADULT • NON-DROWSY

Wal-Tussin ®
DM Max

Cough & Chest Congestion

DEXTROMETHORPHAN HBr / COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT

MAXIMUM STRENGTH

  • Relieves cough,chest congestion & mucus
  • 12 years & older

20 SOFTGELS

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MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM
dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0115
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 10 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
POLYETHYLENE GLYCOL 400
POVIDONE K30
PROPYLENE GLYCOL
WATER
SORBITOL
TITANIUM DIOXIDE
FD&C RED NO. 40
GELATIN, UNSPECIFIED
Product Characteristics
Color red (Light red) Score no score
Shape OVAL (Oblong) Size 20mm
Flavor Imprint Code 242
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0115-20 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 20 CAPSULE, GELATIN COATED in 1 BLISTER PACK This package is contained within the CARTON (0363-0115-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 05/01/2016
Labeler — WALGREENS (008965063)
Registrant — Spirit Pharmaceuticals LLC (179621011)
Establishment
Name Address ID/FEI Operations
Medgel Private Ltd. 677385498 manufacture (0363-0115)

Revised: 11/2021 WALGREENS

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