460 - Mucus Relief

460 - Mucus Relief
SPL v4
SPL
SPL Set ID 3d6c30d7-cd02-44a2-b48e-cd65f2896bfd
Route
ORAL
Published
Effective Date 2024-04-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Imprint: G;1200 Shape: oval Color: white Size: 22 mm Score: 1
Marketing Status
ANDA Active Since 2024-04-23

Description

Guaifenesin 1200 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 1200 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 meal



    • 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
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
Active Ingredient(s)

Guaifenesin 1200 mg

Inactive Ingredients

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

Principal Display Panel
Mucus Relief
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)

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

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 meal



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

Guaifenesin 1200 mg

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel
Mucus Relief
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)

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

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