459 - Mucus Relief

459 - Mucus Relief
SPL v3
SPL
SPL Set ID 3ed75cff-ee25-4105-b0a0-afbe5bc93b62
Route
ORAL
Published
Effective Date 2024-04-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;600 Shape: oval Color: white Size: 16 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-24

Description

Guaifenesin 600 mg 

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 600 mg 

Use(s)
  • 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
Other Information
  • store between 20-25°C (68-77°F)
  • do not use if imprinted safety seal under cap is broken or missing
Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

Active Ingredient(s)

Guaifenesin 600 mg 

Inactive Ingredients

carbomer homopolymer type B; hypromellose, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

Principal Display Panel
Mucus Relief
Ask A Doctor Before Use If
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
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 Breastfeeding,

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)


Structured Label Content

Use(s)
  • 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
Other Information (Other information)
  • store between 20-25°C (68-77°F)
  • do not use if imprinted safety seal under cap is broken or missing
Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM – 5PM EST.

Active Ingredient(s) (Active ingredient(s))

Guaifenesin 600 mg 

Inactive Ingredients (Inactive ingredients)

carbomer homopolymer type B; hypromellose, magnesium stearate,  microcrystalline cellulose, sodium starch glycolate

Principal Display Panel
Mucus Relief
Ask A Doctor Before Use If (Ask a doctor before use if)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
  • cough accompanied by too much phlegm (mucus)
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 Breastfeeding, (If pregnant or breastfeeding,)

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)


Advanced Ingredient Data


Raw Label Data

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