DailyMed - FAMOTIDINE tablet, film coated

NDC Code(s): 68094-054-59, 68094-054-65
Packager: Precision Dose, Inc.
This is a repackaged label.
Source NDC Code(s): 0113-0194

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 27, 2025

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SPL UNCLASSIFIED SECTION
20 mg - For Hospital Use Only - LI1731 Rev. 10/24 - Drug Facts

20 mg

For Hospital Use Only
LI1731 Rev. 10/24

Drug Facts
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Active ingredient (in each tablet)
Famotidine 20 mg

Famotidine 20 mg
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Purpose
Acid reducer

Acid reducer
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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 ...
- 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
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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 ...
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)

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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 ...
- 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
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Other information
read the directions and warnings before use - store at 20°-25°C (68°-77°F) protect from moisture
- read the directions and warnings before use
- store at 20°-25°C (68°-77°F)
- protect from moisture
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Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium ...

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide
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Questions or comments?
1-800-397-9228

1-800-397-9228
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SPL UNCLASSIFIED SECTION
GLUTEN FREE

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

NDC 68094-054-65
Unit Dose Packages of 200 Tablets (20 × 10) per Carton
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SPL UNCLASSIFIED SECTION
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 - LI1731 Rev. 10/24

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

LI1731 Rev. 10/24
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PRINCIPAL DISPLAY PANEL - 20 mg Tablet Blister Pack Carton
PrecisionDose™ 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 ...

PrecisionDose™

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.

LC1735
R0

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

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INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
May 29, 2025	3 (current)	download
May 22, 2024	2	download
Mar 28, 2024	1	download

	RxCUI	RxNorm NAME	RxTTY
1	310273	famotidine 20 MG Oral Tablet	PSN
2	310273	famotidine 20 MG Oral Tablet	SCD

Label: FAMOTIDINE tablet, film coated

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Allergy alert

Ask a doctor before use if you have

Stop use and ask a doctor if

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Safety

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	NDC
1	68094-054-59
2	68094-054-65

Label: FAMOTIDINE tablet, film coated

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

Allergy alert

Ask a doctor before use if you have

Stop use and ask a doctor if

Find additional resources

Safety

Related Resources

More Info on this Drug

FAMOTIDINE tablet, film coated

Number of versions: 3

FAMOTIDINE tablet, film coated

FAMOTIDINE tablet, film coated

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FAMOTIDINE tablet, film coated

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.