COUGH MUCUS RELIEF DM- dextromethorphan hbr and guaifenesin tablet

Cough Mucus Relief DM by

Drug Labeling and Warnings

Cough Mucus Relief DM by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan HBr 20mg

Guaifenesin 400mg

INACTIVE INGREDIENT

microcrystalline cellulose, sodium starch glycolate, talc, colloidal silicon dioxide,magnesium stearate, polyvinyl povidone, maltodextrin, stearic acid

* May contain hydroxypropyl methylcellulose, polyethylene glycol

DOSAGE & ADMINISTRATION

* take with a full glass of water

* swallow whole; do not crush, chew or dissolve

*do not take more than 6 tablets in 24 hours

• adults and children 12 years of age and over: 1 tablet every 4 hours
• children under 12 years of age: Do not use

INDICATIONS & USAGE

* temporarily relieves cough due to minor throat and bronchial irritation associated with the common cold

* helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

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

* 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 condition.

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

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

KEEP OUT OF REACH OF CHILDREN

In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

PURPOSE

Cough Suppressant

Expectorant

OTHER SAFETY INFORMATION

* store at room temperature 25°C (77°F) ; excursions permitted between 15°C - 30°C (59°F - 86°F)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COUGH MUCUS RELIEF DM 
dextromethorphan hbr and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	400 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)

Product Characteristics
Color	white	Score	2 pieces
Shape	OVAL	Size	16mm
Flavor		Imprint Code	S55
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-101-24	24 in 1 BOTTLE; Type 0: Not a Combination Product	02/15/2018
2	NDC: 70692-101-41	4 in 1 PACKAGE; Type 0: Not a Combination Product	12/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	02/15/2018

Labeler - Strive Pharmaceuticals Inc. (080028013)