MUCUS DM EXTENDED RELEASE- dextromethorphan hydrobromide and guaifenesin tablet

Mucus DM Extended Release by

Drug Labeling and Warnings

Mucus DM Extended Release by is a Otc medication manufactured, distributed, or labeled by P & L Development, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each extended-release tablet)

Dextromethorphan HBr 30 mg

Guaifenesin 600 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 inhales 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 of age and older: take 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours
• children under 12 years of age: do not use

Other information

• store between 20º to 25°C (68º to 77°F)

Inactive ingredients

carbomer, colloidal silicon dioxide, D&C yellow #10 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, talc

Questions or comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

Mucus relief DM

guaifenesin 600 mg expectorant

dextromethorphan HBr 30 mg cough suppressant

• 12-hour relief
• controls cough
• thins & loosens mucus

extended-release tablets

*Compare to the active ingredients in Mucinex® DM

*This product is not manufactured or distributed by Reckitt Benckiser LLC, distributor of Mucinex® DM.

TAMPER EVIDENT: DO NOT USE IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERINGS.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

Package Label

WELLNESS BASICS Mucus Relief DM

INGREDIENTS AND APPEARANCE

MUCUS DM EXTENDED RELEASE 
dextromethorphan hydrobromide and guaifenesin tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59726-833
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg

Inactive Ingredients
Ingredient Name	Strength
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CARBOMER 934 (UNII: Z135WT9208)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POVIDONE (UNII: FZ989GH94E)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	YELLOW	Score	no score
Shape	OVAL	Size	16mm
Flavor		Imprint Code	AN038
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59726-833-20	20 in 1 CARTON	01/01/2019
1		1 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
ANDA	ANDA209692	01/01/2019

Labeler - P & L Development, LLC (800014821)