Mucus Relief Er

Mucus Relief Er
SPL v4
SPL
SPL Set ID fd91621b-c969-8851-e053-6294a90ad8b2
Route
ORAL
Published
Effective Date 2024-07-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (600 mg)
Inactive Ingredients
Microcrystalline Cellulose Carbomer Homopolymer Type B (allyl Sucrose Crosslinked) Magnesium Stearate Hypromellose 2910 (5 Mpa.s) 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 2024-07-19

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
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
Do Not Use
  • for children under 12 years of age
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 Ingredient (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

​Expectorant

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
Do Not Use (Do not use)
  • for children under 12 years of age
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

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 Ingredient (in Each Extended Release Bi Layer Tablet) (Active ingredient (in each extended-release bi-layer tablet))

Guaifenesin 600 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)