Drug Facts
2b59f90b-b8fc-03c0-3527-a8efa97fbfe3
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each extended-release tablet) Guaifenesin USP, 1200 mg Dextromethorphan Hydrobromide USP, 60 mg
Purpose
Expectorant Cough suppressant
Medication Information
Purpose
Expectorant Cough suppressant
Description
(in each extended-release tablet) Guaifenesin USP, 1200 mg Dextromethorphan Hydrobromide USP, 60 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
Section 42229-5
Distributed by:
SAM'S WEST, INC.
BENTONVILLE, AR 72716
Made in India
Section 51945-4
Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets
Carton:
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Purposes
Expectorant
Cough suppressant
Warnings
Questions
call 1-888-375-3784 Weekdays (8am - 8pm EST)
You may also report side effects to this phone number.
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
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.
Other Information
- store at 20°C to 25°C (68°F to 77°F)
Active Ingredients
(in each extended-release tablet)
Guaifenesin USP, 1200 mg
Dextromethorphan Hydrobromide USP, 60 mg
Inactive Ingredients
carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
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 right away (1-800-222-1222).
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)
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
Section 42229-5 (42229-5)
Distributed by:
SAM'S WEST, INC.
BENTONVILLE, AR 72716
Made in India
Section 51945-4 (51945-4)
Guaifenesin 1200 mg and Dextromethorphan 60 mg Extended-Release Tablets
Carton:
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purposes
Expectorant
Cough suppressant
Warnings
Questions
call 1-888-375-3784 Weekdays (8am - 8pm EST)
You may also report side effects to this phone number.
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
Do Not Use (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.
Other Information (Other information)
- store at 20°C to 25°C (68°F to 77°F)
Active Ingredients (Active ingredients)
(in each extended-release tablet)
Guaifenesin USP, 1200 mg
Dextromethorphan Hydrobromide USP, 60 mg
Inactive Ingredients (Inactive ingredients)
carbomer homopolymer type B, colloidal silicon dioxide, FD & C Blue #1, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
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 right away (1-800-222-1222).
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)
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
Back to search View SPL set listing Open on DailyMed ↗
Source: dailymed · Ingested: 2026-02-15T12:07:23.710810 · Updated: 2026-03-14T23:10:46.361818