Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (1200 mg) Dextromethorphan (60 mg)

Inactive Ingredients

Silicon Dioxide Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Povidone K90 Povidone K25 Starch, Corn

Identifiers & Packaging

Pill Appearance

Imprint: X;63 Shape: oval Color: white Size: 22 mm Score: 1

Marketing Status

ANDA Active Since 2017-03-17

Medication Information

Purpose

Cough suppressant

Expectorant

Description

(in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 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

Warnings

Do not use

for children under 12 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.

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age: do not use

Questions?

call 1-855-274-4122 You may also report side effects to this phone number.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Other Information

store at 20° to 25°C (68° to 77°F)

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

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.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

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)

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Carton Label)

NDC 0363-0510-65

Walgreens

Compare to the active ingredients in

Maximum Strength Mucinex^® DM^††

WALGREENS

PHARMACIST RECOMMENDED

12 HOUR

Mucus

Relief DM

GUAIFENESIN 1200 mg / EXPECTORANT

DEXTROMETHORPHAN HBr 60 mg /

COUGH SUPPRESSANT

EXTENDED-RELEASE TABLETS

Maximum Strength                 12 Hour

Controls cough
Thins & loosens mucus

14

EXTENDED-

RELEASE

TABLETS

ACTUAL SIZE

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

Warnings

Do not use

for children under 12 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.

Directions

do not crush, chew, or break tablet
take with a full glass of water
this product can be administered without regard for timing of meals
adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours
children under 12 years of age: do not use

Questions?

call 1-855-274-4122 You may also report side effects to this phone number.

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)

Active Ingredients (Active ingredients)

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

Inactive Ingredients (Inactive ingredients)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)

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.

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 (1-800-222-1222) right away.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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)

Package Label Principal Display Panel 1200 Mg/60 Mg (14 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label))

NDC 0363-0510-65

Walgreens

Compare to the active ingredients in

Maximum Strength Mucinex^® DM^††

WALGREENS

PHARMACIST RECOMMENDED

12 HOUR

Mucus

Relief DM

GUAIFENESIN 1200 mg / EXPECTORANT

DEXTROMETHORPHAN HBr 60 mg /

COUGH SUPPRESSANT

EXTENDED-RELEASE TABLETS

Maximum Strength                 12 Hour

Controls cough
Thins & loosens mucus

14

EXTENDED-

RELEASE

TABLETS

ACTUAL SIZE

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", "Warnings": "Do not use for children under 12 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.", "Directions": "do not crush, chew, or break tablet take with a full glass of water this product can be administered without regard for timing of meals adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours children under 12 years of age: do not use", "Questions?": "call 1-855-274-4122 You may also report side effects to this phone number. DISTRIBUTED BY: WALGREEN CO. 200 WILMOT RD., DEERFIELD, IL 60015", "Other information": "store at 20° to 25°C (68° to 77°F)", "Active ingredients": "(in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)", "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.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "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)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label)": "NDC 0363-0510-65 Walgreens Compare to the active ingredients in Maximum Strength Mucinex ® DM †† WALGREENS PHARMACIST RECOMMENDED 12 HOUR Mucus Relief DM GUAIFENESIN 1200 mg / EXPECTORANT DEXTROMETHORPHAN HBr 60 mg / COUGH SUPPRESSANT EXTENDED-RELEASE TABLETS Maximum Strength 12 Hour Controls cough Thins & loosens mucus 14 EXTENDED- RELEASE TABLETS ACTUAL SIZE "}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information