FAMOTIDINE- famotidine tablet, film coated
Precision Dose, Inc.

----------

Famotidine Tablet

20 mg

For Hospital Use Only

Drug Facts

Active ingredient (in each tablet)

Famotidine 20 mg

Purpose

Acid reducer

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

Allergy alert

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

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

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.

Stop use and ask a doctor if

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

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

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)

Directions

Use as directed per healthcare professional.
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

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

GLUTEN FREE

How Supplied

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

Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080

For inquiries call Precision Dose, Inc.
at 1-800-397-9228 or email
druginfo@precisiondose.com

LI1465 Rev. 08/23

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

PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton Label

FAMOTIDINE
famotidine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68094-054(NDC:0113-0194)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L194
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:68094-054-65	10 in 1 CARTON	03/28/2024
1	NDC:68094-054-59	20 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph drug	M001	03/28/2024

Labeler - Precision Dose, Inc. (035886746)

Revised: 2/2024

Document Id: 6512511e-8dcd-48a6-ac44-1360630fbc53

Set id: de42b6c4-c44b-4ec1-b505-fc5266452d57

Version: 1

Effective Time: 20240222

Precision Dose, Inc.