Guaifenesin 400mg

Guaifenesin 400mg
SPL v6
SPL
SPL Set ID d2ab3a1d-6b47-4b4e-b47a-eee79eac2a1e
Route
ORAL
Published
Effective Date 2020-07-02
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 Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid

Identifiers & Packaging

Pill Appearance
Imprint: EB Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-02

Description

Guaifenesin 400 mg

Purpose

Expectorant 


Medication Information

Warnings and Precautions

Warnings

Purpose

Expectorant 

Description

Guaifenesin 400 mg

Pdp

Mucus Relief

Guaifenesin 400mg

50 Tablets

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make

coughs more productive 

Section 50565-1

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)

Section 53414-9

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

Directions

■ do not crush, chew, or break caplet ■ take with a full glass of water

■ adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms

persist. Do not exceed 6 caplets in 24 hours.

■ children under 12 years of age: do not use

Do Not Use

■ for children under 12 years of age 

Drug Facts 

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

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. 

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 Caplet) 

Guaifenesin 400 mg


Structured Label Content

Pdp (PDP)

Mucus Relief

Guaifenesin 400mg

50 Tablets

Uses

helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make

coughs more productive 

Warnings and Precautions (34071-1)

Warnings

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. (1-800-222-1222)

Section 53414-9 (53414-9)

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

Purpose

Expectorant 

Directions

■ do not crush, chew, or break caplet ■ take with a full glass of water

■ adults and children 12 years of age and over: take 1 caplet every 4 hours with a full glass of water while symptoms

persist. Do not exceed 6 caplets 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 

Drug Facts 

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

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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. 

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 Caplet)  (Active ingredient (in each caplet) )

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)