Drug Facts
a1921611-343c-4c2a-846d-c8de19dddab5
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
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
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 or 2 tablets every 12 hours; not more than 4 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.
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India
M.L.No.: 22/MN/AP/2009/F/R
Manufactured for:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Other Information
- tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
- 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 10 (1 X 10) Tablets Carton Label
Healthy Living™
NDC 58602-871-83
Compare to the active
ingredients of Mucinex® DM*
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
Controls Cough
Thins and Loosens Mucus
12
HOUR
62
10 (1 x 10) 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
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 or 2 tablets every 12 hours; not more than 4 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.
Manufactured by:
Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahabubnagar (Dt)-509302
India
M.L.No.: 22/MN/AP/2009/F/R
Manufactured for:
AUROHEALTH LLC
279 Princeton-Hightstown Road
East Windsor, NJ 08520
Other Information (Other information)
- tamper evident: do not use if carton is open or if printed seal on blister is broken or missing
- 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 10 (1 X 10) Tablets Carton Label (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 600 mg/30 mg 10 (1 x 10) Tablets Carton Label)
Healthy Living™
NDC 58602-871-83
Compare to the active
ingredients of Mucinex® DM*
Mucus Relief DM
Guaifenesin and Dextromethorphan HBr
Extended-release Tablets 600 mg/30 mg
EXPECTORANT AND
COUGH SUPPRESSANT
Controls Cough
Thins and Loosens Mucus
12
HOUR
62
10 (1 x 10) Extended-release Tablets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:25.484334 · Updated: 2026-03-14T23:01:57.446196