Xl3 Xpect Mucus Relief

Xl3 Xpect Mucus Relief
SPL v3
SPL
SPL Set ID c2c8bd26-bbf1-c2e6-e053-2995a90a86a7
Route
ORAL
Published
Effective Date 2021-05-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg) Dextromethorphan (20 mg)
Inactive Ingredients
Alcohol Polyethylene Glycol, Unspecified Croscarmellose Sodium Hypromellose, Unspecified Lactose Monohydrate Povidone Silicon Dioxide Stearic Acid Magnesium Stearate Water

Identifiers & Packaging

Pill Appearance
Imprint: XL3;XPECT Shape: oval Color: white Size: 15 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-17

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Purpose

Expectorant Cough suppressant


Medication Information

Purpose

Expectorant Cough suppressant

Description

Guaifenesin 400mg Dextromethorphan HBr 20mg

Uses

■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

Purposes

Expectorant

Cough suppressant

Directions

Adults and children 12 years 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 under 12 years of age: do not use.

Do Not Use

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Package Label

Other Information

■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) ■ Keep in a dry place and do not expose to heat ■ do not use if blister package is torn or damaged.

Inactive Ingredients

alcohol, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate (derived from milk), magnesium stearate, polyethylene glycol, povidone, purified water, stearic acid

Questions Or Comments?

Call toll free 1-855-259-1590 Monday through Friday 9 AM - 5 PM EST.

Pregnancy/breastfeeding

If pregnant or breast-feeding, ask a health professional before use.

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 the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet)

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Ask A Doctor Before Use If You Have

■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask A Doctor Or Pharmacist Before Use If You

■ are taking sedatives or tranquilizers.


Structured Label Content

Uses

■ helps loosen phlegm (mucus) ■ helps thin bronchial secretions to make coughs more productive ■ temporarily relieves cough due to minor sore throat and bronchial irritation associated with the common cold.

Purposes

Expectorant

Cough suppressant

Directions

Adults and children 12 years 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 under 12 years of age: do not use.

Do Not Use (Do not use)

■ if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson’s disease), or for 2 weeks after stopping the MAOI drug.If you do not know if your prescription drug contains a MAOI, ask a doctor or pharmacist before taking this product.

Package Label

Other Information (Other information)

■ store at 25°C (77°F) excursions between 15°-30°C (59°-86°F) ■ Keep in a dry place and do not expose to heat ■ do not use if blister package is torn or damaged.

Inactive Ingredients

alcohol, colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate (derived from milk), magnesium stearate, polyethylene glycol, povidone, purified water, stearic acid

Questions Or Comments? (Questions or Comments?)

Call toll free 1-855-259-1590 Monday through Friday 9 AM - 5 PM EST.

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

If pregnant or breast-feeding, ask a health professional before use.

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)

Keep out of the reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Active Ingredients (in Each Tablet) (Active ingredients (in each tablet))

Guaifenesin 400mg

Dextromethorphan HBr 20mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

■ cough accompanied by excessive phlegm (mucus) ■ persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask A Doctor Or Pharmacist Before Use If You (Ask a doctor or pharmacist before use if you)

■ are taking sedatives or tranquilizers.


Advanced Ingredient Data


Raw Label Data

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