1204a-mei-2025-0314

1204a-mei-2025-0314
SPL v3
SPL
SPL Set ID 2d7aa3c1-5a4f-7197-e063-6394a90aff47
Route
ORAL
Published
Effective Date 2025-05-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Hypromellose 2910 (15 Mpa.s) Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2025-03-14

Description

Drug Facts

Purpose

Expectorant


Medication Information

Warnings and Precautions

Warnings

Purpose

Expectorant

Description

Drug Facts

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

Drug Facts

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 50566-9

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.

Section 50569-3

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)

Section 50570-1

Do not use

■ for children under 12 years of age

Section 53414-9

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

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: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

■ children under 12 years of age: do not use

Other Information

■ store between 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive Ingredients

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments?

1-844-705-4384

Principal Display Panel

Meijer®

NDC 79481-1204-1

COMPARE TO MUCINEX® MAXIMUM STRENGTH ACTIVE INGREDIENT†

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release

Tablets, 1200 mg | Expectorant

12 HOUR

RELIEVES CHEST CONGESTION

THINS AND LOOSENS MUCUS

IMMEDIATE AND EXTENDED RELEASE

14 EXTENDED-RELEASE TABLETS

Actual Size

Active Ingredient (in Each Extended Release Tablet)

Guaifenesin 1200 mg


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

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

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 50566-9 (50566-9)

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.

Section 50569-3 (50569-3)

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)

Section 50570-1 (50570-1)

Do not use

■ for children under 12 years of age

Section 53414-9 (53414-9)

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

Purpose

Expectorant

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: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

■ children under 12 years of age: do not use

Other Information (Other information)

■ store between 20-25ºC (68-77ºF)

■ retain carton for complete product information and warnings

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Questions Or Comments? (Questions or comments?)

1-844-705-4384

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Meijer®

NDC 79481-1204-1

COMPARE TO MUCINEX® MAXIMUM STRENGTH ACTIVE INGREDIENT†

MAXIMUM STRENGTH

Mucus Relief

Guaifenesin Extended-Release

Tablets, 1200 mg | Expectorant

12 HOUR

RELIEVES CHEST CONGESTION

THINS AND LOOSENS MUCUS

IMMEDIATE AND EXTENDED RELEASE

14 EXTENDED-RELEASE TABLETS

Actual Size

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

Guaifenesin 1200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)