Drug Facts

Drug Facts

SPL v12

SPL

SPL Set ID cc20129b-2556-4452-9222-afd503f1e7a4

Route

ORAL

Published

Effective Date 2024-10-03

Document Type 34390-5 Human OTC Drug Label

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

Description

(in each extended-release tablet) Dextromethorphan Hydrobromide USP 30 mg Guaifenesin USP 600 mg

Purpose

Cough suppressant Expectorant

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

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

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)

Package Label Principal Display Panel 600 Mg/30 Mg (14 Tablet Bottle)

NDC 58602-714-05

Mucus Relief DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets 30 mg/ 600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant

RELIEVES COUGH & CHEST CONGESTION

12

HOUR

√ Controls Cough

√ Thins & Loosens Mucus

14 Extended-release Tablets

AUROHEALTH

Package Label Principal Display Panel 600 Mg/30 Mg (14 Tablet Carton Label)

Compare to the active

ingredients of Mucinex® DM*

NDC 58602-714-05

Mucus Relief DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets 30 mg/ 600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant

RELIEVES COUGH & CHEST CONGESTION

12

HOUR

√ Controls Cough

√ Thins & Loosens Mucus

ACTUAL SIZE

14 Extended-release Tablets

AUROHEALTH

Package Label Principal Display Panel 600 Mg/30 Mg Blister Carton 20 (2 X 10) Unit Dose Tablets

Compare to the active

ingredients of Mucinex® DM*

NDC 58602-714-67

Mucus Relief DM

Dextromethorphan HBr and Guaifenesin

Extended-release Tablets 30 mg/ 600 mg

Dextromethorphan HBr 30 mg - Cough Suppressant

Guaifenesin 600 mg - Expectorant

RELIEVES COUGH & CHEST CONGESTION

12

HOUR

√ Controls Cough

√ Thins & Loosens Mucus

ACTUAL SIZE

20 (2 x 10)

Extended-release Tablets

AUROHEALTH

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

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

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)

Package Label Principal Display Panel 600 Mg/30 Mg (14 Tablet Bottle) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Bottle))

Package Label Principal Display Panel 600 Mg/30 Mg (14 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Carton Label))

Package Label Principal Display Panel 600 Mg/30 Mg Blister Carton 20 (2 X 10) Unit Dose Tablets (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose 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", "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", "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)", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Bottle)": "NDC 58602-714-05 Mucus Relief DM Dextromethorphan HBr and Guaifenesin Extended-release Tablets 30 mg/ 600 mg Dextromethorphan HBr 30 mg - Cough Suppressant Guaifenesin 600 mg - Expectorant RELIEVES COUGH & CHEST CONGESTION 12 HOUR √ Controls Cough √ Thins & Loosens Mucus 14 Extended-release Tablets AUROHEALTH", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg (14 Tablet Carton Label)": "Compare to the active ingredients of Mucinex® DM* NDC 58602-714-05 Mucus Relief DM Dextromethorphan HBr and Guaifenesin Extended-release Tablets 30 mg/ 600 mg Dextromethorphan HBr 30 mg - Cough Suppressant Guaifenesin 600 mg - Expectorant RELIEVES COUGH & CHEST CONGESTION 12 HOUR √ Controls Cough √ Thins & Loosens Mucus ACTUAL SIZE 14 Extended-release Tablets AUROHEALTH", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg Blister Carton 20 (2 x 10) Unit-dose Tablets": "Compare to the active ingredients of Mucinex® DM* NDC 58602-714-67 Mucus Relief DM Dextromethorphan HBr and Guaifenesin Extended-release Tablets 30 mg/ 600 mg Dextromethorphan HBr 30 mg - Cough Suppressant Guaifenesin 600 mg - Expectorant RELIEVES COUGH & CHEST CONGESTION 12 HOUR √ Controls Cough √ Thins & Loosens Mucus ACTUAL SIZE 20 (2 x 10) Extended-release Tablets AUROHEALTH"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:40.889704 · Updated: 2026-03-14T23:03:52.479021