ACID REDUCER MAXIMUM STRENGTH- famotodine tablet 
Allegiant Health

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443 - Acid Reducer Maximum Strength

Active ingredient(s)

Famotidine USP 20mg

Purpose

Acid reducer

Use(s)

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

  • 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 breastfeeding,

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

adults and children 12 years and over:

Other information

Inactive ingredients

Hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline
cellulose, pre-gelatinized starch, sodium starch glycolate, talc, titanium dioxide, triacetin

Questions/Comments

Call 1-888-952-0050 Monday through Friday 9AM − 5PM EST

Principal Display Panel

Famotidine Tablets, 20mg

Famotidine Tablets, 20mg

ACID REDUCER  MAXIMUM STRENGTH
famotodine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-443
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE20 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code V;15
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-443-32100 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2024
2NDC:69168-443-52225 in 1 BOTTLE; Type 0: Not a Combination Product01/15/2024
3NDC:69168-443-0910 in 1 BLISTER PACK; Type 0: Not a Combination Product02/29/2024
4NDC:69168-443-501 in 1 CARTON03/05/2024
450 in 1 BOTTLE; Type 0: Not a Combination Product
5NDC:69168-443-99365 in 1 BOTTLE; Type 0: Not a Combination Product10/28/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582201/15/2024
Labeler - Allegiant Health (079501930)

Revised: 1/2024
Document Id: 628b0339-72b6-4c9b-998b-e02fda36f180
Set id: adc2721d-2ca7-4a47-bae1-be298fa1c155
Version: 4
Effective Time: 20240116
 
Allegiant Health