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SPL v7

SPL

SPL Set ID cdd509c4-331b-4aee-935c-dfc44d5943ed

Route

ORAL

Published

Effective Date 2025-04-05

Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients

Famotidine (10 mg)

Inactive Ingredients

Carnauba Wax Starch, Corn Hydroxypropyl Cellulose (1600000 Wamw) Hypromellose 2910 (5 Mpa.s) Magnesium Stearate Microcrystalline Cellulose Ferric Oxide Red Sodium Starch Glycolate Type A Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: CC;58 Shape: round Color: pink Size: 5 mm Score: 1

Marketing Status

ANDA Active Since 2020-04-04

Description

Drug Facts

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Drug Facts

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

Section 42229-5

Drug Facts

Warnings

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

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 15 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

Do Not Use

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.These may be signs of a serious condition. See your doctor.
with other acid reducers

Other Information

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

Inactive Ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments?

call 1-855-274-4122

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

Do not use if carton is open or if printed foil seal under bottle cap is open or torn.

Dist. by CAH, Dublin, OH 43017

1-800-200-6313

Made in India

©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal

Health.

All other marks are the property of their respective owners.

Code: TS/DRUGS/22/2009

Stop Use and Ask A Doctor If

your heartburn continues or worsens
you need to take this product for more than 14 days

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Tablet)

Famotidine USP 10 mg

Ask A Doctor Before Use If You Have

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney disease

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Package Label Principal Display Panel 10 Mg (30 Tablets Container Label)

LEADER_TM

NDC 70000-0048-1

Original Strength

Acid Reducer

Famotidine Tablets USP, 10 mg | Acid Reducer

Just One Tablet!

Prevents & Relieves

Heartburn Due to Acid Indigestion

30 TABLETS                                    100% Money

                                                         Back Guarantee

Package Label Principal Display Panel 10 Mg (30 Tablets Container Carton Label)

LEADER_TM

NDC 70000-0048-1

Original Strength

Acid

Reducer

Famotidine Tablets USP, 10 mg

Acid Reducer

Just One Tablet!

Prevents & Relieves Heartburn

Due to Acid Indigestion

Actual Size                                 COMPARE TO

                                                     ORIGINAL

                                                     STRENGTH

                                                     PEPCID® AC

                                                     active ingredient

30

TABLETS                                    100% Money

                                                     Back Guarantee

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Purpose

Acid reducer

Warnings

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

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 15 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

Do Not Use (Do not use)

if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools.These may be signs of a serious condition. See your doctor.
with other acid reducers

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc and titanium dioxide.

Questions Or Comments? (Questions or comments?)

call 1-855-274-4122

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
Do not eat before bedtime
Raise the head of your bed
Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

your heartburn continues or worsens
you need to take this product for more than 14 days

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 (1-800-222-1222) right away.

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

ask a health professional before use.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Famotidine USP 10 mg

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

had heartburn over 3 months. This may be a sign of a more serious condition.
heartburn with lightheadedness, sweating, or dizziness
chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness
frequent chest pain
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
kidney disease

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

taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Package Label Principal Display Panel 10 Mg (30 Tablets Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Label))

Package Label Principal Display Panel 10 Mg (30 Tablets Container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label))

Advanced Ingredient Data

[{"name": "FAMOTIDINE", "unii": "5QZO15J2Z8", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CARNAUBA WAX", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYPROPYL CELLULOSE (1600000 WAMW)", "unii": "RFW2ET671P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (5 MPA.S)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MICROCRYSTALLINE CELLULOSE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FERRIC OXIDE RED", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TITANIUM DIOXIDE", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "Purpose": "Acid reducer", "Warnings": "Allergy alert: Do not use if you are allergic to famotidine or other acid reducers", "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 15 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", "Do not use": "if you have trouble or pain swallowing food, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor. with other acid reducers", "Other information": "read the directions and warnings before use keep the carton. It contains important information. store at 20° to 25°C (68° to 77°F) protect from moisture", "Inactive ingredients": "carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc and titanium dioxide.", "Questions or comments?": "call 1-855-274-4122 Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight-fitting clothing around the stomach Do not eat before bedtime Raise the head of your bed Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Eat slowly and avoid big meals If overweight, lose weight Quit smoking JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages. Do not use if carton is open or if printed foil seal under bottle cap is open or torn. Dist. by CAH, Dublin, OH 43017 1-800-200-6313 Made in India ©2023 CARDINAL HEALTH, LEADER, and LOGOs are trademarks of Cardinal Health. All other marks are the property of their respective owners. Code: TS/DRUGS/22/2009", "Stop use and ask a doctor if": "your heartburn continues or worsens you need to take this product for more than 14 days", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.", "If pregnant or breast-feeding,": "ask a health professional before use.", "Active ingredient (in each tablet)": "Famotidine USP 10 mg", "Ask a doctor before use if you have": "had heartburn over 3 months. This may be a sign of a more serious condition. heartburn with lightheadedness, sweating, or dizziness chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness frequent chest pain frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain kidney disease ", "Ask a doctor or pharmacist before use if you are": "taking a prescription drug. Acid reducers may interact with certain prescription drugs.", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Label)": "LEADER TM NDC 70000-0048-1 Original Strength Acid Reducer Famotidine Tablets USP, 10 mg | Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion 30 TABLETS 100% Money Back Guarantee", "PACKAGE LABEL-PRINCIPAL DISPLAY PANEL -10 mg (30 Tablets Container Carton Label)": "LEADER TM NDC 70000-0048-1 Original Strength Acid Reducer Famotidine Tablets USP, 10 mg Acid Reducer Just One Tablet! Prevents & Relieves Heartburn Due to Acid Indigestion Actual Size COMPARE TO ORIGINAL STRENGTH PEPCID® AC active ingredient 30 TABLETS 100% Money Back Guarantee"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:54.969979 · Updated: 2026-03-14T23:08:21.075335