SUNMARK MUCUS RELIEF DM- dextromethorphan hbr, guaifenesin tablet, extended release

Sunmark mucus relief DM by

Drug Labeling and Warnings

Sunmark mucus relief DM by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Purpose

Cough Suppressant

Expectorant

Uses

• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
• temporarily relieves:
• cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants
• the intensity of coughing
• the impulse to cough to help you get to sleep

Warnings

Do not use

• for children under 12 years of age
• 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

• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)

When using this product

• do not use more than directed

Stop use and ask a doctor if

• cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.

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. (1-800-222-1222)

Directions

• do not crush, chew, or break tablet
• take with a full glass of water
• this product can be administered without regard for timing of meals
• adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• do not use if printed foil under cap is broken or missing
• store between 20-25°C (68-77°F)

Inactive ingredients

colloidal silicon dioxide, copovidone, D&C yellow #10 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone, sodium starch glycolate Type A, stearic acid

Questions or comments?

1-800-719-9260

Package/Label Principal Display Panel

COMPARE TO MAXIMUM STRENGTH MUCINEX® DM ACTIVE INGREDIENTS

maximum strength

mucus relief DM

Guaifenesin 1200 mg/Dextromethorphan

Hydrobromide 60 mg

Extended-Release Tablets

Expectorant/Cough Suppressant

Controls cough

Thins & loosens mucus

12 HOUR

Actual Size

GLUTEN FREE

14 EXTENDED-RELEASE TABLETS

INGREDIENTS AND APPEARANCE

SUNMARK MUCUS RELIEF DM 
dextromethorphan hbr, guaifenesin tablet, extended release

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-199
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	60 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	1200 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	22mm
Flavor		Imprint Code	Watson;1200
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49348-199-46	1 in 1 CARTON	07/11/2016
1		14 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA091070	07/11/2016

Labeler - Strategic Sourcing Services LLC (116956644)