5688-leader

5688-leader
SPL v2
SPL
SPL Set ID 287525d8-83ef-7110-e063-6294a90ad373
Route
ORAL
Published
Effective Date 2024-12-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Polyethylene Glycol 400 Magnesium Stearate Microcrystalline Cellulose Hypromellose 2910 (5 Mpa.s) Starch, Corn Titanium Dioxide Talc Sodium Starch Glycolate Type A Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: C;29 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2024-12-04

Description

Active ingredient (in each tablet) Famotidine 20 mg


Medication Information

Warnings and Precautions

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

Description

Active ingredient (in each tablet) Famotidine 20 mg

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 34088-5

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

Section 42229-5

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1

Keep out of reach of children.

Section 50566-9

Stop use and ask a doctor if

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 50569-3

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
Section 50570-1

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
Section 51727-6

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.

Section 51945-4

NDC 70000-0710-1

Maximum Strength

Acid Reducer

Famotidine Tablets USP, 20 mg

Just One Tablet Prevents

& Relieves Heartburn Due

to Acid Indigestion

COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*

200

TABLETS

Section 53413-1

Questions or comments?

1-800-231-4670:

weekdays 9am-5pm EST

Section 53414-9

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

Section 55105-1

Purpose

Acid reducer

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
Drug Facts

Active ingredient (in each tablet)

Famotidine 20 mg

Other Information
  • read the directions and warnings before use
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • meets USP Dissolution Test 2

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.
Warnings and Precautions (34071-1)

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

Section 34088-5 (34088-5)

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

Section 42229-5 (42229-5)

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com 1-800-200-6313

*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.

KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 51727-6 (51727-6)

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.

Section 51945-4 (51945-4)

NDC 70000-0710-1

Maximum Strength

Acid Reducer

Famotidine Tablets USP, 20 mg

Just One Tablet Prevents

& Relieves Heartburn Due

to Acid Indigestion

COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*

200

TABLETS

Section 53413-1 (53413-1)

Questions or comments?

1-800-231-4670:

weekdays 9am-5pm EST

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Acid reducer

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
Drug Facts

Active ingredient (in each tablet)

Famotidine 20 mg

Other Information (Other information)
  • read the directions and warnings before use
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
  • meets USP Dissolution Test 2

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)