Maximum Strength

Maximum Strength
SPL v7
SPL
SPL Set ID 00c40e3b-6962-dfb4-e063-6294a90afec6
Route
ORAL
Published
Effective Date 2023-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2023-10-06

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

Warnings

Do not use

■ for children under 12 years of age

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

Q​uestions?

We would love to hear about your Member’s Mark experience! Call us toll-free at 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

Warnings

Do not use

■ for children under 12 years of age

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

Q​uestions?

We would love to hear about your Member’s Mark experience! Call us toll-free at 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 (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

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