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

Purpose

Cough Suppressant Expectorant

Description

Dextromethorphan HBr 30 mg Guaifenesin 600 mg


Medication Information

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
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

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

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

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
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

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

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

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

All Sections (JSON)