Maximum Strength

Maximum Strength
SPL v7
SPL
SPL Set ID a62e2045-8ec2-1771-e053-2995a90a03b4
Route
ORAL
Published
Effective Date 2024-09-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose Hypromellose 2910 (5 Mpa.s) Carbomer Homopolymer Type B (allyl Sucrose Crosslinked)

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2024-09-12

Description

Guaifenesin 1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 mg

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

Principal Display Panel

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 Ingredients (in Each Extended Release Bi Layer 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

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

Principal Display Panel (Principal display panel)

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 Ingredients (in Each Extended Release Bi Layer Tablet) (Active ingredients (in each extended-release bi-layer tablet))

Guaifenesin 1200 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)