Guaifenesin Extended-release Tablets 600 Mg And 1200 Mg

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 2023-08-23

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 1-877-376-4271 (weekdays 9 AM to 5 PM)

You may also report side effects to this phone number.

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83

Verna Indl. Estate

Verna, Goa-403722, India

Principal Display Panel

NDC: 25000-042-55

Guaifenesin Extended-Release Tablets 600 mg

20's count (2 x 10's blister) Carton

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Label

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Carton

NDC: 25000-042-12

Guaifenesin Extended-Release Tablets 600 mg

500's count Bottle Label

NDC: 25000-042-99

Guaifenesin Extended-Release Tablets 600 mg

40's count (2 x 20's blister) Carton

NDC: 25000-041-75

Guaifenesin Extended-Release Tablets 1200 mg

12's count (2 x 6's blister) Carton

NDC: 25000-041-12

Guaifenesin Extended-Release Tablets 1200 mg

500's count Bottle Label

NDC: 25000-041-34

Guaifenesin Extended-Release Tablets 1200 mg

28's count (2 x 14's blister) Carton

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 1-877-376-4271 (weekdays 9 AM to 5 PM)

You may also report side effects to this phone number.

Manufactured for:

Time-Cap Labs, Inc.

7 Michael Avenue,

Farmingdale,

NY 11735, USA

Manufactured by:

Marksans Pharma Ltd.

Plot No. L-82, L-83

Verna Indl. Estate

Verna, Goa-403722, India

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC: 25000-042-55

Guaifenesin Extended-Release Tablets 600 mg

20's count (2 x 10's blister) Carton

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Label

NDC: 25000-042-01

Guaifenesin Extended-Release Tablets 600 mg

20's count Bottle Carton

NDC: 25000-042-12

Guaifenesin Extended-Release Tablets 600 mg

500's count Bottle Label

NDC: 25000-042-99

Guaifenesin Extended-Release Tablets 600 mg

40's count (2 x 20's blister) Carton

NDC: 25000-041-75

Guaifenesin Extended-Release Tablets 1200 mg

12's count (2 x 6's blister) Carton

NDC: 25000-041-12

Guaifenesin Extended-Release Tablets 1200 mg

500's count Bottle Label

NDC: 25000-041-34

Guaifenesin Extended-Release Tablets 1200 mg

28's count (2 x 14's blister) Carton

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

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Raw Label Data

All Sections (JSON)

{"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 1-877-376-4271 (weekdays 9 AM to 5 PM) You may also report side effects to this phone number. Manufactured for: Time-Cap Labs, Inc. 7 Michael Avenue, Farmingdale, NY 11735, USA Manufactured by: Marksans Pharma Ltd. Plot No. L-82, L-83 Verna Indl. Estate Verna, Goa-403722, India ", "PRINCIPAL DISPLAY PANEL": "NDC: 25000-042-55 Guaifenesin Extended-Release Tablets 600 mg 20's count (2 x 10's blister) Carton NDC: 25000-042-01 Guaifenesin Extended-Release Tablets 600 mg 20's count Bottle Label NDC: 25000-042-01 Guaifenesin Extended-Release Tablets 600 mg 20's count Bottle Carton NDC: 25000-042-12 Guaifenesin Extended-Release Tablets 600 mg 500's count Bottle Label NDC: 25000-042-99 Guaifenesin Extended-Release Tablets 600 mg 40's count (2 x 20's blister) Carton NDC: 25000-041-75 Guaifenesin Extended-Release Tablets 1200 mg 12's count (2 x 6's blister) Carton NDC: 25000-041-12 Guaifenesin Extended-Release Tablets 1200 mg 500's count Bottle Label NDC: 25000-041-34 Guaifenesin Extended-Release Tablets 1200 mg 28's count (2 x 14's blister) Carton", "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."}

Guaifenesin Extended-release Tablets 600 Mg And 1200 Mg

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information