Mucus Relief

Mucus Relief
SPL v8
SPL
SPL Set ID fb71526e-b9a4-419c-94e8-0510dddf0b19
Route
ORAL
Published
Effective Date 2020-03-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Magnesium Stearate Maltodextrin Microcrystalline Cellulose Povidone K30 Sodium Starch Glycolate Type A Potato Stearic Acid Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: EB Shape: capsule Color: white Size: 17 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-10

Description

Guaifenesin 400 mg

Purpose

Expectorant


Medication Information

Warnings and Precautions

Warnings

Purpose

Expectorant

Description

Guaifenesin 400 mg

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

Principal Display Panel

Mucus Relief

Guaifenesin 400mg

• Expectorant

• Thins and Loosens Mucus

• Relieves Chest Congestion

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.

Active Ingredient (in Each Caplet)

Guaifenesin 400 mg

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)


Structured Label Content

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Mucus Relief

Guaifenesin 400mg

• Expectorant

• Thins and Loosens Mucus

• Relieves Chest Congestion

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.

Active Ingredient (in Each Caplet) (Active ingredient (in each caplet))

Guaifenesin 400 mg

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)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)