Guaifenesin Extended-release

Guaifenesin Extended-release
SPL v3
SPL
SPL Set ID 608b00c5-a2c7-4514-9b46-02954d6675d6
Route
ORAL
Published
Effective Date 2025-05-27
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 Or Allyl Sucrose Crosslinked) Fd&c Blue No. 1 Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: L2X2 Shape: oval Color: blue Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2023-03-22
Description

Tablets, 600 mg For Hospital Use Only LI1730 Rev. 10/24

Purpose

Expectorant

How Supplied

NDC 68094-048-61 Unit Dose Packages of 100 Tablets (10×10) per Carton

Medication Information

Purpose

Expectorant

How Supplied

NDC 68094-048-61

Unit Dose Packages of 100 Tablets (10×10) per Carton

Description

Tablets, 600 mg For Hospital Use Only LI1730 Rev. 10/24

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

Tablets, 600 mg

For Hospital Use Only

LI1730 Rev. 10/24

Section 50565-1

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)

Section 53414-9

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

Directions
  • Use as directed per healthcare professional.
  • 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: 1 or 2 tablets every 12 hours. Do not exceed 4 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
  • store at 20-25°C (68-77°F)
Inactive Ingredients

Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-800-397-9228

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.
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)
Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 600 mg

Principal Display Panel 600 Mg Tablet Blister Pack Carton

PrecisionDose™

NDC 68094-048-61

Unit Dose

guaiFENesin

Extended-Release

Tablets,

600 mg

100 Tablets

(10 x 10)

(in each extended-release tablet)

Guaifenesin 600 mg....Expectorant.

Directions: do not crush, chew, or

break tablet take with a full glass of water

Unique Bi-Layer Tablet

GLUTEN FREE

USUAL DOSE: See Enclosed Drug Facts

Store at 20-25°C (68-77°F)

Keep out of reach of children.

Hospital Use Only.

LC1384

R0

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

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)

Tablets, 600 mg

For Hospital Use Only

LI1730 Rev. 10/24

Section 50565-1 (50565-1)

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)

Section 53414-9 (53414-9)

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

Purpose

Expectorant

Directions
  • Use as directed per healthcare professional.
  • 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: 1 or 2 tablets every 12 hours. Do not exceed 4 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
How Supplied

NDC 68094-048-61

Unit Dose Packages of 100 Tablets (10×10) per Carton

Other Information (Other information)
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

Carbomer homopolymer type B, FD&C blue #1 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-800-397-9228

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.
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)
Active Ingredient (in Each Extended Release Tablet) (Active ingredient (in each extended-release tablet))

Guaifenesin 600 mg

Principal Display Panel 600 Mg Tablet Blister Pack Carton (PRINCIPAL DISPLAY PANEL - 600 mg Tablet Blister Pack Carton)

PrecisionDose™

NDC 68094-048-61

Unit Dose

guaiFENesin

Extended-Release

Tablets,

600 mg

100 Tablets

(10 x 10)

(in each extended-release tablet)

Guaifenesin 600 mg....Expectorant.

Directions: do not crush, chew, or

break tablet take with a full glass of water

Unique Bi-Layer Tablet

GLUTEN FREE

USUAL DOSE: See Enclosed Drug Facts

Store at 20-25°C (68-77°F)

Keep out of reach of children.

Hospital Use Only.

LC1384

R0

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:11.357883 · Updated: 2026-03-14T23:08:48.977444