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 2024-05-21

Medication Information

Purpose

Cough suppressant Expectorant

Description

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

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

Other Information

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients

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

Questions Or Comments?

Call 1-800-632-6900

PROUDLY DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

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

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 Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

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

NDC 30142-275-14

Kroger_®

health

COMPARE TO THE ACTIVE INGREDIENTS IN

MAXIMUM STRENGTH MUCINEX^® DM EXTENDED-RELEASE

BI-LAYER TABLETS^*

MAXIMUM STRENGTH

Mucus Relief DM

Dextromethorphan HBr and

Guaifenesin Extended-release

Tablets 60 mg/ 1200 mg

Dextromethorphan HBr 60 mg - Cough Suppressant

Guaifenesin 1200 mg - Expectorant

R ELIEVES COUGH & CHEST CONGESTION

12 HOUR

CONTROLS                                        ACTUAL SIZE

COUGH

THINS &                                             14 EXTENDED-RELEASE

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

Other Information (Other information)

store at 20° to 25°C (68° to 77°F)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call 1-800-632-6900

PROUDLY DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

MADE IN INDIA

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

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 Hydrobromide USP 60 mg

Guaifenesin USP 1200 mg

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

NDC 30142-275-14

Kroger_®

health

COMPARE TO THE ACTIVE INGREDIENTS IN

MAXIMUM STRENGTH MUCINEX^® DM EXTENDED-RELEASE

BI-LAYER TABLETS^*

MAXIMUM STRENGTH

Mucus Relief DM

Dextromethorphan HBr and

Guaifenesin Extended-release

Tablets 60 mg/ 1200 mg

Dextromethorphan HBr 60 mg - Cough Suppressant

Guaifenesin 1200 mg - Expectorant

R ELIEVES COUGH & CHEST CONGESTION

12 HOUR

CONTROLS                                        ACTUAL SIZE

COUGH

THINS &                                             14 EXTENDED-RELEASE

LOOSENS MUCUS                             TABLETS

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "1200", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DEXTROMETHORPHAN", "unii": "7355X3ROTS", "classCode": "ACTIB", "strengthNumerator": "60", "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 extended-release tablet every 12 hours; not more than 2 extended-release tablets in 24 hours children under 12 years of age: do not use", "Other information": "store at 20° to 25°C (68° to 77°F)", "Inactive ingredients": "colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)", "Questions or comments?": "Call 1-800-632-6900 PROUDLY DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 MADE IN INDIA", "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 (1-800-222-1222) right away.", "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 Hydrobromide USP 60 mg Guaifenesin USP 1200 mg", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 60 mg/1200 mg (14 Tablets Carton Label)": "NDC 30142-275-14 Kroger ® health COMPARE TO THE ACTIVE INGREDIENTS IN MAXIMUM STRENGTH MUCINEX ® DM EXTENDED-RELEASE BI-LAYER TABLETS * MAXIMUM STRENGTH Mucus Relief DM Dextromethorphan HBr and Guaifenesin Extended-release Tablets 60 mg/ 1200 mg Dextromethorphan HBr 60 mg - Cough Suppressant Guaifenesin 1200 mg - Expectorant R ELIEVES COUGH & CHEST CONGESTION 12 HOUR CONTROLS ACTUAL SIZE COUGH THINS & 14 EXTENDED-RELEASE LOOSENS MUCUS TABLETS"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information