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Guaifenesin

Dosage form
TABLET, EXTENDED RELEASE
Labeler
Amneal Pharmaceuticals LLC
Label updated
2024-10-07
Retrieved
2026-09-07
Active ingredients
GUAIFENESIN
View original label and images on DailyMed ↗
Active ingredient(s)

Active ingredient (in each extended-release tablet)

Guaifenesin 600 mg

Active ingredient (in each extended-release tablet)

Guaifenesin 1200 mg

Purpose

Expectorant

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

Warnings

Do not use

  • for children under 12 years of age

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)

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.

Pregnancy/Breastfeeding

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 right away (1-800-222-1222).

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
Other information
  • Tamper evident: Do not use if printed foil under cap is broken or missing.
Storage
  • store between 20° to 25°C (68° to 77°F)
Inactive ingredients

carbomer, colloidal silicon dioxide, FD&C blue #1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone and talc

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

Label information

[Image in the official label — see DailyMed source]

DailyMed Set ID: ad67e6fd-a68f-44db-9718-84a2cef86e09 · Version 12
NDC: 65162-036, 65162-037