Mucus Relief

Mucus Relief
SPL v6
SPL
SPL Set ID 0a0aa190-8dc7-f9cc-e063-6394a90a6078
Route
ORAL
Published
Effective Date 2024-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2024-08-01

Description

Guaifenesin 600 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg

Uses

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

Warnings

Do not use

 for children under 12 years of age

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

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; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Principal Display Panel

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)

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

Uses

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

Purpose (purpose)

Expectorant

Warnings

Do not use

 for children under 12 years of age

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

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; hypromellose; magnesium stearate; microcrystalline cellulose; sodium starch glycolate

Principal Display Panel (Principal display panel)

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.

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)

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

All Sections (JSON)