370 - Mucus Relief

370 - Mucus Relief
SPL v8
SPL
SPL Set ID e7c68746-7ec0-46cf-b4a3-174fab819b5e
Route
ORAL
Published
Effective Date 2021-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Croscarmellose Sodium Microcrystalline Cellulose Silicon Dioxide Stearic Acid Dibasic Calcium Phosphate Dihydrate Povidone

Identifiers & Packaging

Pill Appearance
Imprint: AH370 Shape: oval Color: white Size: 17 mm Score: 2
Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-12-23

Description

Guaifenesin 400 mg

Purpose

Expectorant


Medication Information

Purpose

Expectorant

Description

Guaifenesin 400 mg

Use(s)

helps loosen phlegm (mucus)and thin bronchial secretions to make

coughs more productive to rid the bronchial passageway of bothersome mucus

Storage
  • store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)
  •  keep in a dry place and do not expose to heat
Questions

Call 1-800-719-9260 Monday through Friday 9AM – 5PM EST.

Directions

Adults and children12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under12 years of age:  do not use

Other Information
  • do not use if imprinted safety seal under cap is broken or missing
Active Ingredient(s)

Guaifenesin 400 mg

Inactive Ingredients

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Pregnancy/breastfeeding

ask a healthcare professional before use.

Principal Display Panel

Mucus Relief
Mucus Relief

When Using This Product
  • do not exceed recommended dosage

  •  do not use for more than 7 days
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 excessive phlegm (mucus)
Stop Use and Ask A Doctor If
  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Structured Label Content

Use(s)

helps loosen phlegm (mucus)and thin bronchial secretions to make

coughs more productive to rid the bronchial passageway of bothersome mucus

Purpose

Expectorant

Storage
  • store at 25°C (77°F) excursions between 15° to 30°C (59° to 86°F)
  •  keep in a dry place and do not expose to heat
Questions

Call 1-800-719-9260 Monday through Friday 9AM – 5PM EST.

Directions

Adults and children12 years of age and older: Take 1 tablet every 4 hours with a full glass of water while symptoms persist. Do not exceed 6 doses in 24 hours.

Children under12 years of age:  do not use

Other Information (Other information)
  • do not use if imprinted safety seal under cap is broken or missing
Active Ingredient(s) (Active ingredient(s))

Guaifenesin 400 mg

Inactive Ingredients (Inactive ingredients)

Croscarmellose Sodium, Maltodextrin, Microcrystalline Cellulose, Povidone, Silicon Dioxide, Stearic Acid

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

ask a healthcare professional before use.

Principal Display Panel

Mucus Relief
Mucus Relief

When Using This Product (When using this product)
  • do not exceed recommended dosage

  •  do not use for more than 7 days
Ask A Doctor Before Use If (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 excessive phlegm (mucus)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts for more than 7 days, recurs, or is accompanied by fever, rash, or persistent headache.

These could be signs of a serious condition.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Advanced Ingredient Data


Raw Label Data

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