Drug Facts
49d7f70d-ff79-0708-3eda-efa5bf61da6c
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
(in each extended-release tablet) Guaifenesin USP, 600 mg Dextromethorphan Hydrobromide USP, 30 mg 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, 600 mg Dextromethorphan Hydrobromide USP, 30 mg 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:
Dr. Reddy’s Laboratories, Inc.
Princeton, NJ 08540
Made in India
Issued: 10/2022
Section 51945-4
Guaifenesin 600 mg and Dextromethorphan 30 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 (9am - 8pm EST)
You may also report side effects to this phone number.
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
- children under 12 years of age: do not use
For 600 mg/30 mg:
- adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.
For 1200 mg/60 mg:
- adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.
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, 600 mg
Dextromethorphan Hydrobromide USP, 30 mg
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:
Dr. Reddy’s Laboratories, Inc.
Princeton, NJ 08540
Made in India
Issued: 10/2022
Section 51945-4 (51945-4)
Guaifenesin 600 mg and Dextromethorphan 30 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 (9am - 8pm EST)
You may also report side effects to this phone number.
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
- children under 12 years of age: do not use
For 600 mg/30 mg:
- adults and children 12 years and older: 1 or 2 tablets every 12 hours; not more than 4 tablets in 24 hours.
For 1200 mg/60 mg:
- adults and children 12 years and older: 1 tablet every 12 hours; not more than 2 tablets in 24 hours.
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, 600 mg
Dextromethorphan Hydrobromide USP, 30 mg
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
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Source: dailymed · Ingested: 2026-02-15T12:02:53.910637 · Updated: 2026-03-14T23:02:40.652524