Label: FAMOTIDINE 10 MG tablet, coated
FAMOTIDINE 20 MG tablet, coated
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NDC Code(s):
25000-086-03,
25000-086-08,
25000-086-36,
25000-087-03, view more25000-087-08, 25000-087-36
- Packager: MARKSANS PHARMA LIMITED
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 13, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Warnings
- Do not use
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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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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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
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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
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Questions or comments?
Call 1-877-376-4271 (weekdays 9 AM to 5 PM)
- JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.
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
NDC: 25000-086-03
Famotidine Tablets USP 10 mg
30's count Bottle Label
NDC: 25000-086-03
Famotidine Tablets USP 10 mg
30's count Carton Label
NDC: 25000-086-08
Famotidine Tablets USP 10 mg
100's count Bottle Label
NDC: 25000-086-08
Famotidine Tablets USP 10 mg
100's count Carton Label
Famotidine Tablets USP, 20 mg
NDC: 25000-087-36
Famotidine Tablets USP 20 mg
30's (3 x 10's blister) count Carton Label
NDC: 25000-087-03
Famotidine Tablets USP 20 mg
30's count Bottle Label
NDC: 25000-087-03
Famotidine Tablets USP 20 mg
30's count Carton Label
NDC: 25000-087-08
Famotidine Tablets USP 20 mg
100's count Bottle Label
NDC: 25000-087-08
Famotidine Tablets USP 20 mg
100's count Carton Label
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INGREDIENTS AND APPEARANCE
FAMOTIDINE 10 MG
famotidine 10 mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-086 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine 10 mg Inactive Ingredients Ingredient Name Strength 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 Color PINK Score no score Shape SQUARE Size 7mm Flavor Imprint Code 86 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-086-36 3 in 1 CARTON 03/10/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:25000-086-03 1 in 1 CARTON 03/10/2023 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:25000-086-08 1 in 1 CARTON 03/10/2023 3 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217543 03/10/2023 FAMOTIDINE 20 MG
famotidine 20 mg tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:25000-087 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Famotidine (UNII: 5QZO15J2Z8) (Famotidine - UNII:5QZO15J2Z8) Famotidine 20 mg Inactive Ingredients Ingredient Name Strength 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 Color WHITE Score no score Shape SEMI-CIRCLE (D-shaped) Size 9mm Flavor Imprint Code 87 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:25000-087-36 3 in 1 CARTON 03/10/2023 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:25000-087-03 1 in 1 CARTON 03/10/2023 2 30 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:25000-087-08 1 in 1 CARTON 03/10/2023 3 100 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA217543 03/10/2023 Labeler - MARKSANS PHARMA LIMITED (925822975) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 MANUFACTURE(25000-086, 25000-087)