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

Purpose

Expectorant

Description

Guaifenesin 1200 mg


Medication Information

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

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

Description

Guaifenesin 1200 mg

Principal Display Panel
Mucus Relief
Use(s)
  •  helps loosen phlegm (mucus) and thin bronchial secretions to rid the

    bronchial passageways of bothersome mucus and make coughs more productive
Do Not Use

for children under 12 years of age

Active Ingredient(s)

Guaifenesin 1200 mg

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

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
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
Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel
Mucus Relief
Use(s)
  •  helps loosen phlegm (mucus) and thin bronchial secretions to rid the

    bronchial passageways of bothersome mucus and make coughs more productive
Do Not Use (Do not use)

for children under 12 years of age

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

Guaifenesin 1200 mg

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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