Mucus Relief DM Extended Release Caplets: Package Insert and Label Information

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS- dextromethorphan hydrobromide and guaifenesin tablet
EQUATE (Wal-Mart Stores, Inc.)

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 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 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 regards for timing of meals
  • adults and children 12 years of age 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

  • 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?

1-888-287-1915

Principal Display Panel

Compare to Maximum Strength Mucinex® DM active ingredients*

Mucus Relief DM

Guaifenesin 1200 mg/

Dextromethorphan HBr 60 mg

Extended-Release Tablets

MAXIMUM STRENGTH

Expectorant/Cough Suppressant

  • Controls Cough
  • Thins & Loosens Mucus

EXTENDED-RELEASE TABLETS

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY: Walmart Inc.,

Bentonville, AR 72716

Package Label

Dextromethorphan HBr 60 mg, Guaifenesin 1200 mg
(click image for full-size original)

EQUATE Mucus Relief DM

MUCUS RELIEF DM EXTENDED RELEASE CAPLETS
guaifenesin, dextromethorphan hbr tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-824
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE 60 mg
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 1200 mg
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934
SILICON DIOXIDE
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POVIDONE
TALC
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 22mm
Flavor Imprint Code AN039
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49035-824-28 1 BOTTLE, PLASTIC in 1 BOX contains a BOTTLE, PLASTIC
1 28 TABLET in 1 BOTTLE, PLASTIC This package is contained within the BOX (49035-824-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209692 11/29/2019
Labeler — EQUATE (Wal-Mart Stores, Inc.) (051957769)

Revised: 01/2020 EQUATE (Wal-Mart Stores, Inc.)

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