Guaifenesin Extended-release Tablets

Guaifenesin Extended-release Tablets
SPL v12
SPL
SPL Set ID ad67e6fd-a68f-44db-9718-84a2cef86e09
Route
ORAL
Published
Effective Date 2024-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Carbomer Copolymer Type A Silicon Dioxide Fd&c Blue No. 1 Hypromelloses Lactose Monohydrate Magnesium Stearate Cellulose, Microcrystalline Povidone Talc

Identifiers & Packaging

Pill Appearance
Imprint: AN037 Shape: oval Color: blue Size: 16 mm Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2018-07-27

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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