MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- guaifenesin, dextromethorphan hbr tablet

Mucus Relief DM Extended Release Caplets by

Drug Labeling and Warnings

Mucus Relief DM Extended Release Caplets by is a Otc medication manufactured, distributed, or labeled by ATLANTIC BIOLOGICALS CORP., Unit Dose Solutions. 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 inhaled irritants
  • the intensity of coughing
  • the impulse to cough to help you get to sleep

Description

Mucus Relief DM ER

Guaifenesin 600 mg (Expectorant)

Dextromethorphan HBr 30 mg (Cough Suppressant)

• 12-hour Relief
• Controls Cough
• Thins & Loosens Mucus

Extended-release tablets, compared to the active ingredients in Mucinex DM.

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

Warnings

Do not use

• for children under12 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 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 (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 regards for timing of meals
• adults and children 12 years of age and older: 1 or 2 tablet 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 25ºC (68º to 77ºF)

Inactive ingredients

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

Questions or comments?

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

Call1-800-509-7592

Monday-Friday 9 AM - 5 PM EST

Package Label

INGREDIENTS AND APPEARANCE

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS 
guaifenesin, dextromethorphan hbr tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17856-1162(NDC:0536-1161)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	600 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	30 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)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
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: 17856-1162-1	100 in 1 CARTON	03/17/2025
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	12/13/2018

Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)

Registrant - ATLANTIC BIOLOGICALS CORP. (047437707)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Solutions		360804194	repack(17856-1162)