Guaifenesin Extended-release Tablets 1200mg

Guaifenesin Extended-release Tablets 1200mg
SPL v6
SPL
SPL Set ID f32e5b0f-1fd9-9b33-e053-2995a90a8103
Route
ORAL
Published
Effective Date 2023-06-30
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) Sodium Starch Glycolate Type A Magnesium Stearate Hypromellose 2910 (5 Mpa.s) Microcrystalline Cellulose

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2023-06-30

Description

Guaifenesin 1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 mg

Pdp

Uses

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

Directions

■ do not crush, chew, or break tablet

■ take with a full glass of water

■ this product can be administered without regard for 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

Do Not Use

■ for children under 12 years of age

Questions?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Other Information

■ Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

■ store between 20-25°C (68-77°F)

Inactive Ingredients

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

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.

If Pregnant Or Breast Feeding,

ask a health professional before use

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)

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 Bi Layer Tablet)

Guaifenesin 1200 mg


Structured Label Content

Pdp (PDP)

Uses

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

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 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

Do Not Use (Do not use)

■ for children under 12 years of age

Questions?

contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Other Information (Other information)

■ Tamper evident: Do not use if carton is open or if printed seal on blister is broken or missing.

■ store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

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

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.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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 a Poison Control Center right away. (1-800-222-1222)

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 Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 1200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)