drug facts
bf4bcec8-7136-4ae7-a459-a30ee881b98d
34390-5
Human OTC Drug Label
Drug Facts
Composition & Product
Identifiers & Packaging
Purpose
Cough suppressant Expectorant
Description
( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Medication Information
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.
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
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
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)
Inactive Ingredients
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)
Description
( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Questions?
call 1-855-274-4122 You may also report side effects to this phone number.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® DM.
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
Active Ingredients
(
in each extended-release tablet)
Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg
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 1200 Mg/60 Mg (14 Tablet Carton Label)
Compare to Maximum
Strength Mucinex® DM
active ingredients*
GOOD
NEIGHBOR
PHARMACY®
NDC 46122-420-74
12 Hour
maximum strength
Mucus . DM
guaifenesin and dextromethorphan HBr
extended-release tablets
1200 mg/60 mg
Expectorant/Cough Suppressant
- Controls Cough
- Thins and Loosens Mucus
14 Extended-Release Tablets
Structured Label Content
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.
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
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
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)
Inactive Ingredients (Inactive ingredients)
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch (maize)
Questions?
call 1-855-274-4122 You may also report side effects to this phone number.
*This product is not manufactured or distributed by Reckitt Benckiser, distributor of Maximum Strength Mucinex® DM.
Distributed By
AmerisourceBergen
1300 Morris Drive
Chesterbrook, PA 19087
Questions or Concerns?
www.mygnp.com
Active Ingredients (Active ingredients)
(
in each extended-release tablet)
Dextromethorphan Hydrobromide USP 60 mg
Guaifenesin USP 1200 mg
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 1200 Mg/60 Mg (14 Tablet Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 1200 mg/60 mg (14 Tablet Carton Label))
Compare to Maximum
Strength Mucinex® DM
active ingredients*
GOOD
NEIGHBOR
PHARMACY®
NDC 46122-420-74
12 Hour
maximum strength
Mucus . DM
guaifenesin and dextromethorphan HBr
extended-release tablets
1200 mg/60 mg
Expectorant/Cough Suppressant
- Controls Cough
- Thins and Loosens Mucus
14 Extended-Release Tablets
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:02:55.749236 · Updated: 2026-03-14T23:02:43.906306