Guaifenesin Extended-release Tablets 600 Mg And 1200 Mg

Guaifenesin Extended-release Tablets 600 Mg And 1200 Mg
SPL v1
SPL
SPL Set ID 10c42869-7df0-3046-e063-6394a90aa679
Route
ORAL
Published
Effective Date 2023-03-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Silicon Dioxide Copovidone K25-31 Hypromellose, Unspecified Magnesium Stearate Maltodextrin Microcrystalline Cellulose 102 Povidone K30 Sodium Starch Glycolate Type A Stearic Acid Fd&c Blue No. 1 Aluminum Lake

Identifiers & Packaging

Pill Appearance
Imprint: 41 Shape: oval Shape: capsule Color: white Size: 16 mm Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2024-01-08

Description

For 600 mg:             Active ingredient (in each extended-release tablet) Guaifenesin, USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg

Purpose

Purpose Expectorant

Storage and Handling

Other information • store at 20-25°C (68-77°F)


Medication Information

Purpose

Purpose Expectorant

Storage and Handling

Other information • store at 20-25°C (68-77°F)

Description

For 600 mg:             Active ingredient (in each extended-release tablet) Guaifenesin, USP 600 mg For 1200 mg: Active ingredient (in each extended-release tablet) Guaifenesin, USP 1200 mg

Otc Purpose Section

Purpose

Expectorant



Otc Stop Use Section

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.
Otc Questions Section

Questions or comments? Call 1-877-290-4008

Principal Display Panel

Otc Ask Doctor Section

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)

Otc Do Not Use Section

Do not use

• for children under 12 years of age

Inactive Ingredient Section

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue No. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

Indications & Usage Section

Uses

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

Storage and Handling Section

Other information

• store at 20-25°C (68-77°F)

Dosage & Administration Section

Directions

For 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



For 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. Do not exceed 2 extended - release tablets in 24 hours.

• children under 12 years of age: do not use



Otc Active Ingredient Section

For 600 mg:            

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg



For 1200 mg:

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

Otc Pregnancy Or Breast Feeding Section

If pregnant or breast-feeding,ask a health professional before use.

Otc Keep Out of Reach of Children Section

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Otc Purpose Section (OTC - PURPOSE SECTION)

Purpose

Expectorant



Otc Stop Use Section (OTC - STOP USE SECTION)

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.
Otc Questions Section (OTC - QUESTIONS SECTION)

Questions or comments? Call 1-877-290-4008

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Otc Ask Doctor Section (OTC - ASK DOCTOR SECTION)

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)

Otc Do Not Use Section (OTC - DO NOT USE SECTION)

Do not use

• for children under 12 years of age

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive ingredients colloidal silicon dioxide, copovidone, FD&C blue No. 1 aluminum lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, povidone (K-30), sodium starch glycolate, stearic acid

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Uses

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

Storage and Handling Section (STORAGE AND HANDLING SECTION)

Other information

• store at 20-25°C (68-77°F)

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions

For 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



For 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. Do not exceed 2 extended - release tablets in 24 hours.

• children under 12 years of age: do not use



Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

For 600 mg:            

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 600 mg



For 1200 mg:

Active ingredient (in each extended-release tablet)

Guaifenesin, USP 1200 mg

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

If pregnant or breast-feeding,ask a health professional before use.

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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