drug facts

Composition & Product

Active Ingredients

guaifenesin (100 mg)

Inactive Ingredients

aspartame silicon dioxide starch, corn d&c yellow no. 10 lactose monohydrate magnesium stearate povidone k30 sodium starch glycolate type a potato

Identifiers & Packaging

Pill Appearance

Imprint: FORTUNE Shape: round Color: yellow Size: 10 mm Score: 1

Marketing Status

otc monograph drug active Since 2016-04-26

Medication Information

Warnings and Precautions

Warnings

Active Ingredient

Active ingredients (in each tablet)

Guaifenesin 100 mg

Indications and Usage

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to:

rid the bronchial passageways of bothersome mucus

make coughs more productive

Dosage and Administration

Directions

adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours

children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours

children under 6 years of age: consult a doctor

Description

Active ingredients (in each tablet) Guaifenesin 100 mg

Section 44425-7

Other information

 Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet

keep tightly sealed

 store between 20 to 25º C (68 to 77º F)

Section 50565-1

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

any of the following occurs (these could be signs of a serious condition):

   cough persists for more than 1 week

   cough tends to recur

   cough is accompanied by a fever, rash, or persistent headache

Section 50569-3

Ask a doctor before use if the user has

a persistent or chronic cough such as occurs with:

   smoking

   asthma

   chronic bronchitis

   emphysema

a cough that is accompanied by excessive phlegm (mucus)

a high fever

Section 51727-6

Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.

Section 51945-4

EXCAUGH

Guaifenesin - Expectorant

NDC 51467-009-02

36 Tablets

Section 53413-1

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Purpose

Expectorant

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

Active Ingredient (55106-9)

Active ingredients (in each tablet)

Guaifenesin 100 mg

Indications and Usage (34067-9)

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to:

rid the bronchial passageways of bothersome mucus

make coughs more productive

Dosage and Administration (34068-7)

Directions

adults and children 12 years of age and over: take 2 to 4 tablets every 4 hours, not to exceed 24 tablets (2,400 mg) in 24 hours

children 6 to under 12 years of age: take 1 to 2 tablets every 4 hours, not to exceed 12 tablets (1,200 mg) in 24 hours

children under 6 years of age: consult a doctor

Section 44425-7 (44425-7)

Other information

 Phenylketonurics: Contains Phenylalanine 3.929 mg Per Tablet

keep tightly sealed

 store between 20 to 25º C (68 to 77º F)

Section 50565-1 (50565-1)

Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

any of the following occurs (these could be signs of a serious condition):

   cough persists for more than 1 week

   cough tends to recur

   cough is accompanied by a fever, rash, or persistent headache

Section 50569-3 (50569-3)

Ask a doctor before use if the user has

a persistent or chronic cough such as occurs with:

   smoking

   asthma

   chronic bronchitis

   emphysema

a cough that is accompanied by excessive phlegm (mucus)

a high fever

Section 51727-6 (51727-6)

Inactive ingredients aspartame, colloidal silicon dioxide, corn starch, D&C yellow no.10 aluminum lake, lactose monohydrate, magnesium stearate, povidone K30, sodium starch glycolate.

Section 51945-4 (51945-4)

EXCAUGH

Guaifenesin - Expectorant

NDC 51467-009-02

36 Tablets

Section 53413-1 (53413-1)

Questions or comments? (888) 221-3496 M-F 9 am to 5 pm

you may also report serious side effects to this phone number

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Expectorant

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

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