Famotidine Tablet

Famotidine Tablet
SPL v1
SPL
SPL Set ID 2f73ec98-c2c3-7acd-e063-6294a90a49d9
Route
ORAL
Published
Effective Date 2024-04-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Carnauba Wax Silicon Dioxide Croscarmellose Sodium Lactose Monohydrate Magnesium Stearate Microcrystalline Cellulose Polyethylene Glycol, Unspecified Polyvinyl Alcohol, Unspecified Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: L194 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2024-03-28

Description

20 mg For Hospital Use Only Drug Facts

Purpose

Acid reducer

How Supplied

NDC 68094-054-65 Unit Dose Packages of 200 Tablets (20 × 10) per Carton


Medication Information

Purpose

Acid reducer

How Supplied

NDC 68094-054-65

Unit Dose Packages of 200 Tablets

(20 × 10) per Carton

Description

20 mg For Hospital Use Only 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

20 mg

For Hospital Use Only

Drug Facts

Section 50565-1

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

Section 50568-5

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

Section 53414-9

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

Directions
  • Use as directed per healthcare professional.
  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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
Allergy Alert

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

Other Information
  • read the directions and warnings before use
  • 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?

1-800-397-9228

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
Active Ingredient (in Each Tablet)

Famotidine 20 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
Principal Display Panel 20 Mg Tablet Blister Pack Carton Label

Precision Dose™

NDC 68094-054-65

Unit Dose

Famotidine

Tablets 20 mg

200 Tablets

(20 x 10)

(in each tablet)

Famotidine 20 mg

Acid reducer

Directions

To relieve symptoms, swallow 1 tablet

with a glass of water. Do not chew.

GLUTEN FREE

USUAL DOSE: SEE ENCLOSED DRUG FACTS

Store at 20°-25°C (68°-77°F)

protect from moisture

Keep out of reach of children.

Hospital Use Only.

LC1464

R1

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080


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)

20 mg

For Hospital Use Only

Drug Facts

Section 50565-1 (50565-1)

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

Section 50568-5 (50568-5)

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

Section 53414-9 (53414-9)

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

Purpose

Acid reducer

Directions
  • Use as directed per healthcare professional.
  • adults and children 12 years and over:
    • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes beforeeating 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
How Supplied

NDC 68094-054-65

Unit Dose Packages of 200 Tablets

(20 × 10) per Carton

Allergy Alert (Allergy alert)

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

Other Information (Other information)
  • read the directions and warnings before use
  • store at 20°-25°C (68°-77°F)
  • protect from moisture
Inactive Ingredients (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? (Questions or comments?)

1-800-397-9228

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

Famotidine 20 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
Principal Display Panel 20 Mg Tablet Blister Pack Carton Label (PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label)

Precision Dose™

NDC 68094-054-65

Unit Dose

Famotidine

Tablets 20 mg

200 Tablets

(20 x 10)

(in each tablet)

Famotidine 20 mg

Acid reducer

Directions

To relieve symptoms, swallow 1 tablet

with a glass of water. Do not chew.

GLUTEN FREE

USUAL DOSE: SEE ENCLOSED DRUG FACTS

Store at 20°-25°C (68°-77°F)

protect from moisture

Keep out of reach of children.

Hospital Use Only.

LC1464

R1

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)