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NDC 55111-0396-13 Famotidine 20 mg/1 Details

Famotidine 20 mg/1

Famotidine is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Dr.Reddys Laboratories Limited. The primary component is FAMOTIDINE.

MedlinePlus Drug Summary

Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.

Related Packages: 55111-0396-13
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Famotidine

Product Information

NDC	55111-0396
Product ID	55111-396_0e165efa-c6cc-c254-e143-a757293c26b3
Associated GPIs	49200030000320
GCN Sequence Number	011677
GCN Sequence Number Description	famotidine TABLET 20 MG ORAL
HIC3	Z2D
HIC3 Description	HISTAMINE H2-RECEPTOR INHIBITORS
GCN	46430
HICL Sequence Number	004521
HICL Sequence Number Description	FAMOTIDINE
Brand/Generic	Generic
Proprietary Name	Famotidine
Proprietary Name Suffix	n/a
Non-Proprietary Name	Famotidine
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	20
Active Ingredient Units	mg/1
Substance Name	FAMOTIDINE
Labeler Name	Dr.Reddys Laboratories Limited
Pharmaceutical Class	Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077367
Listing Certified Through	2024-12-31

Package

Package Images

NDC 55111-0396-13 (55111039613)

Pricing Information	N/A
NDC Package Code	55111-396-13
Billing NDC	55111039613
Package	1 BOTTLE in 1 CARTON (55111-396-13) / 130 TABLET in 1 BOTTLE
Marketing Start Date	2020-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 387088a6-8eaa-fc49-8050-a546d0f0fd32 Details

Active ingredient (in each tablet)

Famotidine USP, 10 mg/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

For Famotidine 10 mg:
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
For Famotidine 20 mg:
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
keep the carton. It contains important information.
store at 20°-25°C (68°-77°F)
protect from moisture and light

Inactive ingredients

colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, synthetic red iron oxide (only in 10 mg), talc and titanium dioxide

Questions or comments?

call 1-888-375-3784

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

Famotidine 10 mg

Container Label

PRINCIPAL DISPLAY PANEL

Container Carton Label

PRINCIPAL DISPLAY PANEL

Famotidine 20 mg

Container Label

PRINCIPAL DISPLAY PANEL

Container Carton Label

INGREDIENTS AND APPEARANCE

FAMOTIDINE

famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-118
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	10 mg

Ingredient Name	Strength
Inactive Ingredients
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	PINK	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	C;118
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-118-30	1 in 1 CARTON	09/30/2006
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-118-40	1 in 1 CARTON	10/01/2020
2		40 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-118-60	1 in 1 CARTON	09/30/2006
3		60 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-118-90	1 in 1 CARTON	09/30/2006
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-118-04	1 in 1 CARTON	10/01/2020
5		120 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-118-18	1 in 1 CARTON	09/30/2006
6		180 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-118-24	4 in 1 CARTON	09/30/2006
7		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
8	NDC:55111-118-35	3 in 1 CARTON	09/30/2006
8		6 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:55111-118-81	3 in 1 CARTON	09/30/2006
9		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
10	NDC:55111-118-79	1 in 1 CARTON	09/30/2006
10		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
11	NDC:55111-118-12	1 in 1 CARTON	09/30/2006
11		12 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
ANDA	ANDA077367	09/30/2006

FAMOTIDINE

famotidine tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55111-396
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
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
Polyethylene Glycol, Unspecified (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	WHITE	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code	L1
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55111-396-35	1 in 1 CARTON	09/30/2006
1		25 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC:55111-396-50	1 in 1 CARTON	09/30/2006
2		50 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC:55111-396-65	1 in 1 CARTON	10/01/2020
3		65 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC:55111-396-90	1 in 1 CARTON	10/07/2021
4		90 in 1 BOTTLE; Type 0: Not a Combination Product
5	NDC:55111-396-44	2 in 1 CARTON	09/30/2006
5	NDC:55111-396-01	100 in 1 BOTTLE; Type 0: Not a Combination Product
6	NDC:55111-396-13	1 in 1 CARTON	10/01/2020
6		130 in 1 BOTTLE; Type 0: Not a Combination Product
7	NDC:55111-396-32	1 in 1 CARTON	09/30/2006
7		170 in 1 BOTTLE; Type 0: Not a Combination Product
8	NDC:55111-396-08	1 in 1 CARTON	09/30/2006
8		8 in 1 BLISTER PACK; Type 0: Not a Combination Product
9	NDC:55111-396-16	5 in 1 CARTON	09/30/2006
9		5 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
ANDA	ANDA077367	09/30/2006

Labeler - Dr.Reddys Laboratories Limited (650562841)

Name	Address	ID/FEI	Business Operations
Establishment
Dr.Reddys Laboratories Limited		918608162	analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)

Name	Address	ID/FEI	Business Operations
Establishment
Reed Lane Inc		001819879	pack(55111-118, 55111-396)

Name	Address	ID/FEI	Business Operations
Establishment
Dr. Reddy's Laboratories Louisiana LLC		830397282	analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)

Revised: 8/2021

Document Id: 0e165efa-c6cc-c254-e143-a757293c26b3

Set id: 387088a6-8eaa-fc49-8050-a546d0f0fd32

Version: 11

Effective Time: 20210818

Search by Drug Name or NDC

NDC 55111-0396-13 Famotidine 20 mg/1 Details

Famotidine 20 mg/1

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 55111-0396-13 (55111039613)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 387088a6-8eaa-fc49-8050-a546d0f0fd32 Details

Active ingredient (in each tablet)

Purpose

Uses

Warnings

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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