FAMOTIDINE 10 MG - famotidine 10 mg tablet, coated 
FAMOTIDINE 20 MG - famotidine 20 mg tablet, coated 
MARKSANS PHARMA LIMITED

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Famotidine Tablets USP, 10 mg and 20 mg

Active ingredient (in each tablet)

For 10 mg:

Famotidine USP 10 mg


For 20 mg:

Famotidine USP 20 mg

Purpose

Acid Reducer

Uses

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 10mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o do not use more than 2 tablets in 24 hours
• children under 12 years: ask a doctor


For 20 mg:

• adults and children 12 years and over:
o to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
o 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
o 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
• FDA approved dissolution test specifications differ from USP



Inactive ingredients

For 10 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, red iron oxide, talc, titanium dioxide


For 20 mg:

carnauba wax, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide

Questions or comments?

Call 1-877-376-4271 (weekdays 9 AM to 5 PM)



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



Manufactured for:
Time-Cap Labs, Inc.
7 Michael Avenue,
Farmingdale,
NY 11735, USA


Manufactured by:
Marksans Pharma Ltd.
Plot No. L-82, L-83
Verna Indl. Estate
Verna, Goa-403722, India 

PRINCIPAL DISPLAY PANEL

Famotidine Tablets USP, 10 mg


NDC: 25000-086-36

Famotidine Tablets USP 10 mg

30's (3 x 10's blister) count Carton Label


famo-10-mg-blister-ifc-3x10s


NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Bottle Label


famo-10mg-label-30s


NDC: 25000-086-03

Famotidine Tablets USP 10 mg

30's count Carton Label


famo-10mg-ifc-30s


NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Bottle Label


famo-10mg-label-100s


NDC: 25000-086-08

Famotidine Tablets USP 10 mg

100's count Carton Label


famo-10mg-ifc-100s


Famotidine Tablets USP, 20 mg


NDC: 25000-087-36

Famotidine Tablets USP 20 mg

30's (3 x 10's blister) count Carton Label


famo-20-mg-blister-ifc-3x10s


NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Bottle Label


famo-20mg-label-30s


NDC: 25000-087-03

Famotidine Tablets USP 20 mg

30's count Carton Label


famo-20mg-ifc-30s


NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Bottle Label


famo-20mg-label-100s


NDC: 25000-087-08

Famotidine Tablets USP 20 mg

100's count Carton Label


famo-20mg-ifc-100s


NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Carton Label


famo-20mg-ifc-200s


NDC: 25000-087-82

Famotidine Tablets USP 20 mg

200's count Bottle Label


famo-20mg-label-200s

FAMOTIDINE 10 MG 
famotidine 10 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-086
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine10 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
STARCH, CORN (UNII: O8232NY3SJ)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeSQUARESize7mm
FlavorImprint Code 86
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-086-363 in 1 CARTON03/10/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:25000-086-031 in 1 CARTON03/10/2023
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-086-081 in 1 CARTON03/10/2023
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:25000-086-071 in 1 CARTON04/24/2024
490 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21754303/10/2023
FAMOTIDINE 20 MG 
famotidine 20 mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:25000-087
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine20 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE 102 (UNII: PNR0YF693Y)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeSEMI-CIRCLE (D-shaped) Size9mm
FlavorImprint Code 87
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:25000-087-363 in 1 CARTON03/10/2023
110 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:25000-087-031 in 1 CARTON03/10/2023
230 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:25000-087-081 in 1 CARTON03/10/2023
3100 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:25000-087-051 in 1 CARTON04/24/2024
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:25000-087-821 in 1 CARTON02/15/2024
5200 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21754303/10/2023
Labeler - MARKSANS PHARMA LIMITED (925822975)
Establishment
NameAddressID/FEIBusiness Operations
MARKSANS PHARMA LIMITED925822975MANUFACTURE(25000-086, 25000-087)

Revised: 4/2024
Document Id: 87e4fcca-eef4-4551-bf53-8205e707f880
Set id: 58b653eb-6539-4b79-9d22-df6eaf35307f
Version: 4
Effective Time: 20240423
 
MARKSANS PHARMA LIMITED