Giltuss Ex Expectorant

Giltuss Ex Expectorant
SPL v6
SPL
SPL Set ID a8c53c14-ba82-2c68-e053-2a95a90a9894
Route
ORAL
Published
Effective Date 2020-06-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Guaifenesin (400 mg)
Inactive Ingredients
Polyethylene Glycol, Unspecified Sodium Citrate Water Glycerin Sucralose Anhydrous Citric Acid Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-22

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over 10 mL every 4 hours
    children 6 to under 12 years of age 5 mL every 4 hours
    children 4 to under 6 years of age 2.5 mL every 4 hours
    children under 4 years of age Consult a doctor
Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifcough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 51727-6

Inactive ingredients citric acid, glycerin, methylparaben. natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Section 51945-4

MAXIMUM STRENGTH

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

Section 53413-1

Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9

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

Section 55105-1

Purpose

Expectorant

Section 55106-9

Active ingredient (in each 10 mL)

Guaifenesin, 400 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • do not take more than 6 doses in any 24-hour period
  • use enclosed dosing cup
  • keep dosage cup for use with this product
  • ml = milliliters
    adults and children 12 years and over 10 mL every 4 hours
    children 6 to under 12 years of age 5 mL every 4 hours
    children 4 to under 6 years of age 2.5 mL every 4 hours
    children under 4 years of age Consult a doctor
Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

  • store at room temperature 15°-30°C (59°-86°F)
  • close cap tightly
  • SAVE CARTON FOR COMPLETE DRUG FACTS
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcough lasts for more than 1 week, tends to recur, or is accompanied by fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Section 51727-6 (51727-6)

Inactive ingredients citric acid, glycerin, methylparaben. natural and artificial flavor, polyethylene glycol, propylparaben, purified water, sodium citrate, sucralose.

Section 51945-4 (51945-4)

MAXIMUM STRENGTH

Giltuss® EX EXPECTORANT

ALCOHOL FREE. SUGAR FREE. DYE FREE. NON-DROWSY

RELIEVES

CHEST CONGESTION

LOOSENS AND LIQUIFIES PHLEGM

LIQUIFIES AND REMOVE MUCUS

HELPS TO EXPEL PHLEGM IN CHEST AND THROAT

TUTTI FRUTTI FLAVOR

4FL OZ (118 mL)

Section 53413-1 (53413-1)

Questions or comments? Call 1-787-848-9114, Monday-Friday 9AM - 5PM EST. Call your doctor for medical advice in the event of side effects.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Expectorant

Section 55106-9 (55106-9)

Active ingredient (in each 10 mL)

Guaifenesin, 400 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)