Guaifenesin Extended-release Tablets
ad67e6fd-a68f-44db-9718-84a2cef86e09
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg
Purpose
Expectorant
Medication Information
Purpose
Expectorant
Description
Active ingredient (in each extended-release tablet) Guaifenesin 600 mg Active ingredient (in each extended-release tablet) Guaifenesin 1200 mg
Uses
helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Section 42229-5
Storage
- store between 20° to 25°C (68° to 77°F)
Questions
1-877-835-5472 You may also report side effects to this phone number.
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 10-2024-01
Directions
600 mg
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
1200 mg
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 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
Other Information
- Tamper evident: Do not use if printed foil under cap is broken or missing.
Active Ingredient(s)
Active ingredient (in each extended-release tablet)
Guaifenesin 600 mg
Active ingredient (in each extended-release tablet)
Guaifenesin 1200 mg
Inactive Ingredients
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
Pregnancy/breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
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)
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.
Section 42229-5 (42229-5)
Purpose
Expectorant
Storage
- store between 20° to 25°C (68° to 77°F)
Questions
1-877-835-5472 You may also report side effects to this phone number.
Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807
Rev. 10-2024-01
Directions
600 mg
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 1 or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours.
- children under 12 years of age: do not use
1200 mg
- do not crush, chew, or break extended-release tablet
- take with a full glass of water
- this product can be administered without regard for the timing of meals
- adults and children 12 years of age and over: 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
Other Information (Other information)
- Tamper evident: Do not use if printed foil under cap is broken or missing.
Active Ingredient(s) (Active ingredient(s))
Active ingredient (in each extended-release tablet)
Guaifenesin 600 mg
Active ingredient (in each extended-release tablet)
Guaifenesin 1200 mg
Inactive Ingredients (Inactive ingredients)
carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc
Pregnancy/breastfeeding (Pregnancy/Breastfeeding)
If pregnant or breast-feeding, ask a health professional before use.
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)
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)
Advanced Ingredient Data
Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:04:02.114879 · Updated: 2026-03-14T23:04:28.287489