Mucus Relief Dm Extended Release

Mucus Relief Dm Extended Release
SPL v5
SPL
SPL Set ID 308f50dd-e8d6-0264-e063-6394a90afa68
Route
ORAL
Published
Effective Date 2025-03-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg) Dextromethorphan (30 mg)
Inactive Ingredients
Silicon Dioxide Magnesium Stearate Carbomer 934 Cellulose, Microcrystalline Povidone D&c Yellow No. 10 Hypromellose, Unspecified Lactose Monohydrate Talc

Identifiers & Packaging

Pill Appearance
Imprint: AN038 Shape: oval Color: yellow Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2018-12-13

Description

Dextromethorphan HBr 30 mg Guaifenesin 600 mg

Purpose

Cough Suppressant Expectorant


Medication Information

Purpose

Cough Suppressant

Expectorant

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

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 or 2 tablet every 12 hours; not more than 4 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

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

Call 1-800-509-7592

Monday-Friday 9 AM - 5 PM EST

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).

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 30 mg

Guaifenesin 600 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 or 2 tablet every 12 hours; not more than 4 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.
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

Package Label

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?)

DISTRIBUTED BY:

ATLANTIC BIOLOGICALS CORP.

20101 NE 16TH PL

MIAMI, FL 33179

Call 1-800-509-7592

Monday-Friday 9 AM - 5 PM EST

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 condition.

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 30 mg

Guaifenesin 600 mg


Advanced Ingredient Data


Raw Label Data

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