Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (100 mg)

Inactive Ingredients

Acesulfame Potassium Aspartame Hypromellose, Unspecified Menthol, Unspecified Form Methylparaben Potassium Sorbate Water Anhydrous Citric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 1996-01-01

Medication Information

Purpose

Expectorant

Description

Guaifenesin 100 mg

Uses

•
helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Directions

•
take every 4 hours
•
do not exceed 6 doses in 24 hours

adults & children 12 years and over	10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years	5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years	2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years	ask a doctor

Other Information

•
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
•
store at room temperature 20-25°C (68-77°F).
•
keep tightly closed.

Inactive Ingredients

Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions Or Comments?

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Rev #063:05 10/11

Stop Use and Ask A Doctor If:

•
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts

These could be signs of a serious condition.

If Pregnant Or Breast Feeding,

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.

Active Ingredient (in Each 5 Ml)

Guaifenesin 100 mg

Ask A Doctor Before Use If You Have:

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

Package/label Principal Display Panel

NDC 61787-063-04

Diabetic Tussin^®

Guaifenesin 100 mg/5 mL

Expectorant

Loosens & Relieves Chest Congestion

Thins & Loosens Mucus

Liquid

No Sodium, Sorbitol, Fructose & Dyes

SUGAR & ALCOHOL FREE!

SAFE FOR DIABETICS

4 FL OZ (118 mL)

Structured Label Content

Uses

•
helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus

Purpose

Expectorant

Directions

•
take every 4 hours
•
do not exceed 6 doses in 24 hours

adults & children 12 years and over	10 mL - 20 mL (2 - 4 teaspoonfuls)
children 6 years to under 12 years	5 mL - 10 mL (1 - 2 teaspoonfuls)
children 2 years to under 6 years	2.5 mL - 5 mL (½ - 1 teaspoonful)
children under 2 years	ask a doctor

Other Information (Other information)

•
Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL)
•
store at room temperature 20-25°C (68-77°F).
•
keep tightly closed.

Inactive Ingredients (Inactive ingredients)

Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.

Questions Or Comments? (Questions or comments?)

Call 1-800-899-3116, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

Rev #063:05 10/11

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 headache that lasts

These could be signs of a serious condition.

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

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.

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Guaifenesin 100 mg

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

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

Package/label Principal Display Panel (Package/Label Principal Display Panel)

NDC 61787-063-04

Diabetic Tussin^®

Guaifenesin 100 mg/5 mL

Expectorant

Loosens & Relieves Chest Congestion

Thins & Loosens Mucus

Liquid

No Sodium, Sorbitol, Fructose & Dyes

SUGAR & ALCOHOL FREE!

SAFE FOR DIABETICS

4 FL OZ (118 mL)

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ASPARTAME", "unii": "Z0H242BBR1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE, UNSPECIFIED", "unii": "3NXW29V3WO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL, UNSPECIFIED FORM", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "• helps loosen phlegm (mucus) and thin bronchial secretions to rid bronchial passageways of bothersome mucus", "Purpose": "Expectorant", "Directions": "• take every 4 hours • do not exceed 6 doses in 24 hours adults & children 12 years and over 10 mL - 20 mL (2 - 4 teaspoonfuls) children 6 years to under 12 years 5 mL - 10 mL (1 - 2 teaspoonfuls) children 2 years to under 6 years 2.5 mL - 5 mL (½ - 1 teaspoonful) children under 2 years ask a doctor", "Other information": "• Phenylketonurics: contains phenylalanine 8.4 mg per teaspoonful (5 mL) • store at room temperature 20-25°C (68-77°F). • keep tightly closed.", "Inactive ingredients": "Acesulfame K, artificial cherry flavor, artificial vanilla flavor, aspartame, hypromellose, menthol, methylparaben, potassium sorbate, purified water. Citric acid may be used to adjust pH.", "Questions or comments?": "Call 1-800-899-3116 , Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number. Rev #063:05 10/11", "Stop use and ask a doctor if:": "• cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts These could be signs of a serious condition.", "If pregnant or breast-feeding,": "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.", "Active ingredient (in each 5 mL)": "Guaifenesin 100 mg", "Ask a doctor before use if you have:": "• a cough that occurs with too much phlegm (mucus) • a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema", "Package/Label Principal Display Panel": "NDC 61787-063-04 Diabetic Tussin ® Guaifenesin 100 mg/5 mL Expectorant Loosens & Relieves Chest Congestion Thins & Loosens Mucus Liquid No Sodium, Sorbitol, Fructose & Dyes SUGAR & ALCOHOL FREE! SAFE FOR DIABETICS 4 FL OZ (118 mL)"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information