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

MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM by

Drug Labeling and Warnings

MAXIMUM STRENGTH COUGH PLUS CHEST CONGESTION DM by is a Otc medication manufactured, distributed, or labeled by WALGREENS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
GLYCERIN (UNII: PDC6A3C0OX)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE K30 (UNII: U725QWY32X)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red (Light red)	Score	no score
Shape	OVAL (Oblong)	Size	20mm
Flavor		Imprint Code	242
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-0115-20	1 in 1 CARTON	12/12/2017
1		20 in 1 BLISTER PACK; Type 0: Not a Combination Product

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	Business Operations
Medgel Private Ltd.		677385498	manufacture(0363-0115)