Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 469c5f00-1b6c-6fc7-a352-65764ff25d45

Route

ORAL

Published

Effective Date 2024-10-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Guaifenesin (600 mg)

Inactive Ingredients

Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked) Silicon Dioxide Ferric Oxide Red Hydroxypropyl Cellulose (110000 Wamw) Hypromellose 2910 (10000 Mpa.s) Hypromellose 2208 (4000 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Sodium Starch Glycolate Type A Potato

Identifiers & Packaging

Marketing Status

ANDA Active Since 2022-03-15

Description

Guaifenesin USP, 600 mg (for 600mg) Guaifenesin USP, 1200 mg (for 1200 mg)

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin USP, 600 mg (for 600mg) Guaifenesin USP, 1200 mg (for 1200 mg)

Use(s)

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

Section 42229-5

Distributed by:

McKesson Corp., via Strategic Sourcing Services LLC.

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

Product of India

Section 51945-4

Guaifenesin Extended-Release Tablets 1200 mg

Carton Label

Warnings

Directions

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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
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 (for 1200 mg)
children under 12 years of age: do not use

Do Not Use

For children under 12 years age

Questions?

call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

You may also report side effects to this phone number.

Other Information

store at 20-25°C (68-77°F)

Active Ingredient(s)

Guaifenesin USP, 600 mg (for 600mg)

Guaifenesin USP, 1200 mg (for 1200 mg)

Inactive Ingredients

carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Principal Display Panel

Guaifenesin Extended-Release Tablets 600 mg

Carton Label

Ask A Doctor Before Use If

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 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.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

Structured Label Content

Use(s)

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

Section 42229-5 (42229-5)

Distributed by:

McKesson Corp., via Strategic Sourcing Services LLC.

Memphis, TN 38141

Money Back Guarantee

www.fosterandthrive.com

Product of India

Section 51945-4 (51945-4)

Guaifenesin Extended-Release Tablets 1200 mg

Carton Label

Purpose

Expectorant

Warnings

Directions

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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg)
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 (for 1200 mg)
children under 12 years of age: do not use

Do Not Use (Do not use)

For children under 12 years age

Questions?

call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST

You may also report side effects to this phone number.

Other Information (Other information)

store at 20-25°C (68-77°F)

Active Ingredient(s) (Active ingredient(s))

Guaifenesin USP, 600 mg (for 600mg)

Guaifenesin USP, 1200 mg (for 1200 mg)

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A

Principal Display Panel

Guaifenesin Extended-Release Tablets 600 mg

Carton Label

Ask A Doctor Before Use If (Ask a doctor before use if)

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 Doctor If (Stop use and ask 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.

If Pregnant Or Breastfeeding, (If Pregnant or breastfeeding,)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222).

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "helps loosen phlegum (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive", "42229-5": "Distributed by: McKesson Corp., via Strategic Sourcing Services LLC. Memphis, TN 38141 Money Back Guarantee www.fosterandthrive.com Product of India", "51945-4": "Guaifenesin Extended-Release Tablets 1200 mg Carton Label", "Purpose": "Expectorant", "Directions": "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: 1or 2 extended-release tablets every 12 hours. Do not exceed 4 extended-release tablets in 24 hours (for 600 mg) 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 (for 1200 mg) children under 12 years of age: do not use", "Do not use": "For children under 12 years age", "Questions?": "call 1-833-358-6431 Monday to Friday 9:00am to 7:00pm EST You may also report side effects to this phone number.", "Other information": "store at 20-25°C (68-77°F)", "Active ingredient(s)": "Guaifenesin USP, 600 mg (for 600mg) Guaifenesin USP, 1200 mg (for 1200 mg)", "Inactive ingredients": "carbomer homopolymer type B, colloidal silicon dioxide, ferric oxide red, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate type A", "Principal Display Panel": "Guaifenesin Extended-Release Tablets 600 mg Carton Label", "Ask a doctor before use if": "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 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.", "If Pregnant or breastfeeding,": "ask a health professional before use.", "Keep out of reach of children": "In case of overdose, get medical help or contact aPoison Control Center right away (1-800-222-1222)."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:22.597195 · Updated: 2026-03-14T23:05:04.083969