Mucus Relief Er

Mucus Relief Er
SPL v4
SPL
SPL Set ID fd913bc8-9e1e-3a63-e053-6394a90a34fb
Route
ORAL
Published
Effective Date 2024-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (1200 mg)
Inactive Ingredients
Hypromellose 2910 (5 Mpa.s) Sodium Starch Glycolate Type A Magnesium Stearate Microcrystalline Cellulose Carbomer Homopolymer Type B (allyl Sucrose Crosslinked)

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2024-06-13

Description

Guaifenesin 1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 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 tablet every 12 hours. Do not exceed

2 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

 do not use if foil inner seal 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 1200 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 tablet every 12 hours. Do not exceed

2 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)

 do not use if foil inner seal 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

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 1200 mg


Advanced Ingredient Data


Raw Label Data

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