Guaifenesin

Guaifenesin
SPL v5
SPL
SPL Set ID a62d427e-f339-f225-e053-2a95a90ab387
Route
ORAL
Published
Effective Date 2022-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Hypromellose 2910 (5 Mpa.s) Sodium Starch Glycolate Type A Microcrystalline Cellulose Magnesium Stearate

Identifiers & Packaging

Pill Appearance
Imprint: G;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2021-12-31

Description

Guaifenesin 600 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 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 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

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; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Stop Use and Ask 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 Breat 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 600 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 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

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; hypromellos, magnesium stearate, microcrystalline cellulose, sodium starch glycolate

Stop Use and Ask Doctor If (Stop use and ask 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 Breat Feeding, (If pregnant or breat-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 600 mg


Advanced Ingredient Data


Raw Label Data

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