FAMOTIDINE- famotidine tablet 
Dr.Reddys Laboratories Limited

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Dr.Reddy's Laboratories Limited

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

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

Famotidine 10 mg

Container Label

container10mg

Container Carton Label

carton10mg

Famotidine 20 mg

Container Label

container20mg

Container Carton Label

carton20mg

FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-118
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorPINKScoreno score
ShapeROUNDSize6mm
FlavorImprint Code C;118
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-118-301 in 1 CARTON09/30/2006
130 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-118-401 in 1 CARTON10/01/2020
240 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-118-601 in 1 CARTON09/30/2006
360 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-118-901 in 1 CARTON09/30/2006
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-118-041 in 1 CARTON10/01/2020
5120 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-118-181 in 1 CARTON09/30/2006
6180 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-118-244 in 1 CARTON09/30/2006
76 in 1 BLISTER PACK; Type 0: Not a Combination Product
8NDC:55111-118-353 in 1 CARTON09/30/2006
86 in 1 BLISTER PACK; Type 0: Not a Combination Product
9NDC:55111-118-813 in 1 CARTON09/30/2006
910 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:55111-118-791 in 1 CARTON09/30/2006
1010 in 1 BLISTER PACK; Type 0: Not a Combination Product
11NDC:55111-118-121 in 1 CARTON09/30/2006
1112 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736709/30/2006
FAMOTIDINE 
famotidine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55111-396
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScoreno score
ShapeROUNDSize8mm
FlavorImprint Code L1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55111-396-351 in 1 CARTON09/30/2006
125 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55111-396-501 in 1 CARTON09/30/2006
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:55111-396-651 in 1 CARTON10/01/2020
365 in 1 BOTTLE; Type 0: Not a Combination Product
4NDC:55111-396-901 in 1 CARTON10/07/2021
490 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:55111-396-442 in 1 CARTON09/30/2006
5100 in 1 BOTTLE; Type 0: Not a Combination Product
6NDC:55111-396-011 in 1 CARTON09/30/2006
6100 in 1 BOTTLE; Type 0: Not a Combination Product
7NDC:55111-396-131 in 1 CARTON10/01/2020
7130 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:55111-396-321 in 1 CARTON09/30/2006
8170 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:55111-396-081 in 1 CARTON09/30/2006
98 in 1 BLISTER PACK; Type 0: Not a Combination Product
10NDC:55111-396-165 in 1 CARTON09/30/2006
105 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07736709/30/2006
Labeler - Dr.Reddys Laboratories Limited (650562841)
Establishment
NameAddressID/FEIBusiness Operations
Dr.Reddys Laboratories Limited918608162analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)
Establishment
NameAddressID/FEIBusiness Operations
Reed Lane Inc001819879pack(55111-118, 55111-396)
Establishment
NameAddressID/FEIBusiness Operations
Dr. Reddy's Laboratories Louisiana LLC830397282analysis(55111-118, 55111-396) , manufacture(55111-118, 55111-396)

Revised: 8/2021
 
Dr.Reddys Laboratories Limited