mucus relief

mucus relief
SPL v5
SPL
SPL Set ID 90a14918-d25c-4474-a780-4cc100d8d54f
Route
oral
Published
Effective Date 2021-11-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
guaifenesin (400 mg)
Inactive Ingredients
silicon dioxide magnesium stearate maltodextrin microcrystalline cellulose pyrrolidine sodium starch glycolate type a corn stearic acid

Identifiers & Packaging

Pill Appearance
Imprint: EB Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2021-11-19

Purpose

Expectorant

Description

Guaifenesin 400 mg


Medication Information

Warnings

Do not use for children under 12 years of age

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 • adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. • children under 12 years of age: do not use

Other Information

• store between 20-25°C (68-77°F)

Inactive Ingredients

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Description

Guaifenesin 400 mg

Pouch

Drug Facts

Distributed By:

Cabinet Health P.B.C.

Questions Or Comments?

1-888-333-9792

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)

Active Ingredient (in Each Tablet)

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have

• with persistent or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema • cough accompanied by


Structured Label Content

Warnings

Do not use for children under 12 years of age

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 • adults and children 12 years of age and over: take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 tablets in 24 hours. • children under 12 years of age: do not use

Other Information (Other information)

• store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, magnesium stearate, maltodextrin, microcrystalline cellulose, polyvinyl pyrrolidone, sodium starch glycolate, stearic acid

Pouch

Drug Facts

Distributed By: (Distributed by:)

Cabinet Health P.B.C.

Questions Or Comments? (Questions or comments?)

1-888-333-9792

Stop Use and Ask A Doctor (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)

Active Ingredient (in Each Tablet) (Active Ingredient (in each tablet))

Guaifenesin 400 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

• with persistent or chronic cough such as occurs with smoking,

asthma, chronic bronchitis, or emphysema • cough accompanied by


Advanced Ingredient Data


Raw Label Data

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