Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (600 mg) Dextromethorphan (30 mg)

Inactive Ingredients

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

Identifiers & Packaging

Pill Appearance

Imprint: X;62 Shape: oval Color: white Size: 16 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 30 mg Guaifenesin USP 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

Purposes

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 extended-release 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
children under 12 years of age: do not use

Questions?

call 1-855-274-4122

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

^‡1-888-723-3929

MADE IN INDIA

Other Information

store at 20° to 25°C (68° to 77°F)

Active Ingredients

(in each extended-release tablet)

Dextromethorphan Hydrobromide USP 30 mg

Guaifenesin USP 600 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 600 Mg/30 Mg (20 Tablet Blister Carton Label)

COMPARE TO

Mucinex^® DM active ingredients*

NDC 21130-997-67

Signature

SELECT^™

MUCUS RELIEF

DM

RELIEVES COUGH &

CHEST CONGESTION

DEXTROMETHORPHAN HBr AND GUAIFENESIN

EXTENDED-RELEASE TABLETS 30 mg/600 mg

Cough Suppressant & Expectorant

12

HOUR

Controls Cough

Thins & Loosens Mucus

Actual Size

20 EXTENDED-RELEASE TABLETS

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

Purposes

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 extended-release 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours
children under 12 years of age: do not use

Questions?

call 1-855-274-4122

DISTRIBUTED BY:

BETTER LIVING BRANDS LLC

P.O. BOX 99, PLEASANTON, CA 94566-0009

^‡1-888-723-3929

MADE IN INDIA

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 30 mg

Guaifenesin USP 600 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 600 Mg/30 Mg (20 Tablet Blister Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (20 Tablet Blister Carton Label))

COMPARE TO

Mucinex^® DM active ingredients*

NDC 21130-997-67

Signature

SELECT^™

MUCUS RELIEF

DM

RELIEVES COUGH &

CHEST CONGESTION

DEXTROMETHORPHAN HBr AND GUAIFENESIN

EXTENDED-RELEASE TABLETS 30 mg/600 mg

Cough Suppressant & Expectorant

12

HOUR

Controls Cough

Thins & Loosens Mucus

Actual Size

20 EXTENDED-RELEASE TABLETS

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "600", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K90", "unii": "RDH86HJV5Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K25", "unii": "K0KQV10C35", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

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", "Purposes": "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 extended-release 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 or 2 extended-release tablets every 12 hours; not more than 4 extended-release tablets in 24 hours children under 12 years of age: do not use", "Questions?": "call 1-855-274-4122 DISTRIBUTED BY: BETTER LIVING BRANDS LLC P.O. BOX 99, PLEASANTON, CA 94566-0009 ‡ 1-888-723-3929 MADE IN INDIA", "Other information": "store at 20° to 25°C (68° to 77°F)", "Active ingredients": "(in each extended-release tablet) Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 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 - 600 mg/30 mg (20 Tablet Blister Carton Label)": "COMPARE TO Mucinex ® DM active ingredients* NDC 21130-997-67 Signature SELECT ™ MUCUS RELIEF DM RELIEVES COUGH & CHEST CONGESTION DEXTROMETHORPHAN HBr AND GUAIFENESIN EXTENDED-RELEASE TABLETS 30 mg/600 mg Cough Suppressant & Expectorant 12 HOUR Controls Cough Thins & Loosens Mucus Actual Size 20 EXTENDED-RELEASE TABLETS"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information