Leader Acid Reducer

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2025-08-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:11:19

Key Label Information

Active Ingredients And Purpose

Active ingredient (in each tablet)

Famotidine 20 mg

Purpose

Acid reducer

Uses

Uses

• relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

Warnings

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Directions And Dosage

Directions

• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

Other Label Information

Other information

• read the directions and warnings before use • keep the carton. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

1-800-719-9260

Principal Display Panel

LEADER TM Maximum Strength Acid Reducer Famotidine Tablets, 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion COMPARE TO MAXIMUM STRENGTH PEPCID ® AC active ingredient Actual Size 100% Money Back Guarantee 50 TABLETS SEE NEW WARNINGS

Label Images

leader-acid-reducer-carton-image
leader-acid-reducer-carton-image

Products

NDC Codes

Ingredients

Complete SPL Sections

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Famotidine 20 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer

Uses

INDICATIONS & USAGE SECTION

• relieves heartburn associated with acid indigestion and sour stomach • prevents heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages

Warnings

WARNINGS SECTION

Allergy alert: Do not use if you are allergic to famotidine or other acid reducers

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 years and over: • to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. • to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn • do not use more than 2 tablets in 24 hours • children under 12 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• read the directions and warnings before use • keep the carton. It contains important information. • store at 20°-25°C (68°-77°F) • protect from moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM Maximum Strength Acid Reducer Famotidine Tablets, 20 mg Acid Reducer Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion COMPARE TO MAXIMUM STRENGTH PEPCID ® AC active ingredient Actual Size 100% Money Back Guarantee 50 TABLETS SEE NEW WARNINGS

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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10dbe19bf9b554dc87b32070c474e69bdd3f82ada7a8dc4ce6918910d1a93806
XML bytes
25904

Legacy File Index

FolderFileDate
otc563bca3a-1a43-4520-ac66-3aecd0d3c5fd.xml2025-08-23
otcleader-acid-reducer-carton-image.jpg2025-08-23
otcf3897f81-a3d2-457c-b8ff-c795c99e4e5b.xml2025-02-12
otc24e7b72f-7a05-4d1b-8840-70e012603495.xml2024-01-30
otcimage-01.jpg2024-01-30