Drug Facts
3b5c5617-8499-7fc8-e063-6394a90aa86c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
( in each extended-release tablet) Dextromethorphan Hydrobromide USP 60 mg Guaifenesin USP 1200 mg
Purpose
Cough suppressant Expectorant
Medication Information
Purpose
Cough suppressant Expectorant
Description
( in each extended-release tablet) 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
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 60 mg
Guaifenesin USP 1200 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
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
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 60 mg
Guaifenesin USP 1200 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 (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:08:33.674516 · Updated: 2026-03-14T23:12:49.502411