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 Completed Since 2019-01-31 Until 2026-08-28

Medication Information

Purpose

Cough Suppressant

Expectorant

Description

Dextromethorphan HBr 30 mg Guaifenesin 600 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 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

LEADER 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 MUCINEX® DM active ingredients*

Mucus Relief DM

Dextromethorphan HBr, 30 mg

Guaifenesin, 600 mg

Cough Suppressant | expectorant

12-hour relief

Controls Cough

Thins & Loosens Mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of 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 CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

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 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.

Package Label

LEADER 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 MUCINEX® DM active ingredients*

Mucus Relief DM

Dextromethorphan HBr, 30 mg

Guaifenesin, 600 mg

Cough Suppressant | expectorant

12-hour relief

Controls Cough

Thins & Loosens Mucus

EXTENDED-RELEASE TABLETS

*This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of 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 CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

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 30 mg

Guaifenesin 600 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"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": "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": "LEADER 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 MUCINEX® DM active ingredients* Mucus Relief DM Dextromethorphan HBr, 30 mg Guaifenesin, 600 mg Cough Suppressant | expectorant 12-hour relief Controls Cough Thins & Loosens Mucus EXTENDED-RELEASE TABLETS *This product is not manufactured or distributed Reckitt Benckiser LLC, distributor of 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 CARDINAL HEALTH DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 ©2019 Cardinal Health", "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 30 mg Guaifenesin 600 mg"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information