Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID ebc1a915-f643-4878-9d7a-67a9c6a26b20
Route
ORAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (60 mg) Guaifenesin (1200 mg)
Inactive Ingredients
Carbomer 934 Silicon Dioxide D&c Yellow No. 10 Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Povidone Talc

Identifiers & Packaging

Pill Appearance
Imprint: AN039 Shape: oval Color: yellow Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2025-04-01
Description

Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

Purpose

Cough Suppressant Expectorant

Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 60 mg Guaifenesin 1200 mg

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
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 
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.
Package Label
FAMILY WELLNESS Maximum Strength Mucus Relief DM
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?

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

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENTS IN MAXIMUM STRENGTH MUCINEX® DM

MAXIMUM STRENGTH

MUCUS RELIEF DM

Guaifenesin 1200 mg /

Dextromethorphan HBr 60 mg /

EXTENDED-RELEASE TABLETS

Expectorant / Cough Suppressant

  • 12-hour relief
  • Controls Cough
  • Thins and loosens mucus

Extended-Release Tablets

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

MIDWOOD BRANDS LLC,

510 VOLVO PKWY

CHESAPEAKE, VA 23320

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).

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)
Active Ingredients (in Each Extended Release tablet)

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Structured Label Content

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
Purpose

Cough Suppressant

Expectorant

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 
Do Not Use (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.
Package Label
FAMILY WELLNESS Maximum Strength Mucus Relief DM
Other Information (Other information)
  • store between 20º to 25ºC (68º to 77ºF)
Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

*COMPARE TO THE ACTIVE INGREDIENTS IN MAXIMUM STRENGTH MUCINEX® DM

MAXIMUM STRENGTH

MUCUS RELIEF DM

Guaifenesin 1200 mg /

Dextromethorphan HBr 60 mg /

EXTENDED-RELEASE TABLETS

Expectorant / Cough Suppressant

  • 12-hour relief
  • Controls Cough
  • Thins and loosens mucus

Extended-Release Tablets

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

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

DISTRIBUTED BY:

MIDWOOD BRANDS LLC,

510 VOLVO PKWY

CHESAPEAKE, VA 23320

When Using This Product, (When using this product,)

do not use more than directed. 

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (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)
Active Ingredients (in Each Extended Release tablet) (Active ingredients (in each extended-release tablet))

Dextromethorphan HBr 60 mg

Guaifenesin 1200 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:50.401426 · Updated: 2026-03-14T23:13:20.000214