Leader Adult Tussin Mucus And Chest Congestion 541

SPL v1

SPL

SPL Set ID d7fae410-9c1c-4231-9fde-2c51ad3d7e95

Route

ORAL

Published

Effective Date 2024-09-20

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Guaifenesin (200 mg)

Inactive Ingredients

Anhydrous Citric Acid Fd&c Red No. 40 Glycerin Menthol High Fructose Corn Syrup Propylene Glycol Water Saccharin Sodium Sodium Benzoate Caramel

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-09-20

Description

Guaifenesin, USP 200 mg

Purpose

Expectorant

Medication Information

Purpose

Expectorant

Description

Guaifenesin, USP 200 mg

Use(s)

helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

Warnings

Directions

shake well before using

do not take more than 6 doses in any 24-hour period

measure only with dosing cup provided

keep dosing cup with product

ml=milliliter

this adult product is not intended for use in children under 12 years of age

Age	Dose
adults & children 12 years & over	10 mL to 20 mL every 4 hours
children under 12 years	ask a doctor

Other Information

each 10 mL contains: sodium 12 mg
store at 20-25^oC(68-77^oF)
protect from light

Active Ingredient(s)

Guaifenesin, USP 200 mg

Inactive Ingradients

caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.

Questions Or Comments?

(609) 860-2600

Principal Display Panel

LEADER_TM

NDC70000-0696-1

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor

For Ages 12 and Over

Loosens and Relieves Mucus and

Chest Congestion

100% Money Back Guarantee

4FL OZ(118 mL)

LEADER TM

NDC70000-0696-2

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor

For Ages 12 and Over

Loosens and Relieves Mucus and

Chest Congestion

100% Money Back Guarantee

8FL OZ (237 mL)

Stop Use and Ask Doctor If

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

Keep Out of Reach of Children

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

If Pregnant Or Breast Feeding,

ask a health professional before use.

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm(mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Structured Label Content

Use(s) (USE(S))

helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes

Purpose (PURPOSE)

Expectorant

Warnings (WARNINGS)

Directions (DIRECTIONS)

shake well before using

do not take more than 6 doses in any 24-hour period

measure only with dosing cup provided

keep dosing cup with product

ml=milliliter

this adult product is not intended for use in children under 12 years of age

Age	Dose
adults & children 12 years & over	10 mL to 20 mL every 4 hours
children under 12 years	ask a doctor

Other Information (OTHER INFORMATION)

each 10 mL contains: sodium 12 mg
store at 20-25^oC(68-77^oF)
protect from light

Active Ingredient(s) (ACTIVE INGREDIENT(S))

Guaifenesin, USP 200 mg

Inactive Ingradients (INACTIVE INGRADIENTS)

caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate.

Questions Or Comments? (QUESTIONS OR COMMENTS?)

(609) 860-2600

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

LEADER_TM

NDC70000-0696-1

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor

For Ages 12 and Over

Loosens and Relieves Mucus and

Chest Congestion

100% Money Back Guarantee

4FL OZ(118 mL)

LEADER TM

NDC70000-0696-2

Adult Tussin

Mucus + Chest Congestion

Guaifenesin, USP 200 mg per 10 mL

Expectorant

Cherry Flavor

For Ages 12 and Over

Loosens and Relieves Mucus and

Chest Congestion

100% Money Back Guarantee

8FL OZ (237 mL)

Stop Use and Ask Doctor If (STOP USE AND ASK DOCTOR IF)

cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache.

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.

If Pregnant Or Breast Feeding, (IF PREGNANT OR BREAST-FEEDING,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (ASK A DOCTOR BEFORE USE IF YOU HAVE)

cough that occurs with too much phlegm(mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema

Advanced Ingredient Data

[{"name": "GUAIFENESIN", "unii": "495W7451VQ", "classCode": "ACTIB", "strengthNumerator": "200", "strengthDenominator": "10", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HIGH FRUCTOSE CORN SYRUP", "unii": "XY6UN3QB6S", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARAMEL", "unii": "T9D99G2B1R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USE(S)": "helps loosen phlegm(mucus) and thin bronchial secretions to drain bronchial tubes", "PURPOSE": "Expectorant", "WARNINGS": ".", "DIRECTIONS": "shake well before using do not take more than 6 doses in any 24-hour period measure only with dosing cup provided keep dosing cup with product ml=milliliter this adult product is not intended for use in children under 12 years of age Age Dose adults & children 12 years & over 10 mL to 20 mL every 4 hours children under 12 years ask a doctor", "OTHER INFORMATION": "each 10 mL contains: sodium 12 mg store at 20-25 o C(68-77 o F) protect from light", "ACTIVE INGREDIENT(S)": "Guaifenesin, USP 200 mg ", "INACTIVE INGRADIENTS": "caramel color, citric acid anhydrous, FD&C red# 40 dye, flavor, glycerin, high fructose corn syrup, menthol, propylene glycol, purified water, saccharine sodium, sodium benzoate. ", "QUESTIONS OR COMMENTS?": "(609) 860-2600", "PRINCIPAL DISPLAY PANEL": "LEADER TM NDC70000-0696-1 Adult Tussin Mucus + Chest Congestion Guaifenesin, USP 200 mg per 10 mL Expectorant Cherry Flavor For Ages 12 and Over Loosens and Relieves Mucus and Chest Congestion 100% Money Back Guarantee 4FL OZ(118 mL) LEADER TM NDC70000-0696-2 Adult Tussin Mucus + Chest Congestion Guaifenesin, USP 200 mg per 10 mL Expectorant Cherry Flavor For Ages 12 and Over Loosens and Relieves Mucus and Chest Congestion 100% Money Back Guarantee 8FL OZ (237 mL)", "STOP USE AND ASK DOCTOR IF": "cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. ", "KEEP OUT OF REACH OF CHILDREN": "In case of overdose, get medical help or contact a Poison Control Center right away.", "IF PREGNANT OR BREAST-FEEDING,": "ask a health professional before use.", "ASK A DOCTOR BEFORE USE IF YOU HAVE": "cough that occurs with too much phlegm(mucus) cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis or emphysema"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:36.594474 · Updated: 2026-03-14T23:03:47.044278