Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 99307c61-5df3-0a83-1e21-ddb03bc905b4
Route
ORAL
Published
Effective Date 2022-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

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 600 mg (for 600mg) Guaifenesin 1200 mg (for 1200 mg)

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg (for 600mg) Guaifenesin 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:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

I 07/2022

Section 51945-4

OTC Medicine

Guaifenesin Extended-Release Tablets 1200 mg Carton Label

Warnings

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

Directions

  • do not crush, chew, or break 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 1-888-375-3784 Weekdays (9am - 8pm 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 600 mg (for 600mg)

Guaifenesin 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

OTC Medicine

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 Pregnancy/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:

Dr. Reddy’s Laboratories, Inc.

Princeton, NJ 08540

Made in India

I 07/2022

Section 51945-4 (51945-4)

OTC Medicine

Guaifenesin Extended-Release Tablets 1200 mg Carton Label

Purpose

Expectorant

Warnings

Applicable warning(s) in 201.66(c)(5)(i) and (ii)

Directions

  • do not crush, chew, or break 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 1-888-375-3784 Weekdays (9am - 8pm 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 600 mg (for 600mg)

Guaifenesin 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

OTC Medicine

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 Pregnancy/breastfeeding, (If Pregnancy/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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:20.583129 · Updated: 2026-03-14T23:03:21.577672