HEARTBURN RELIEF- famotidine tablet, film coated 
Shield Pharmaceuticals Corp

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Heartburn Relief

Drug Facts

Active ingredient (in each liquid-filled capsule)

Famotidine 10 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 aretaking

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

adults and children 12 years and over:

  • to relievesymptoms, swallow 1 tablet with a glass of water. Do not chew.
  • to preventsymptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes beforeeating 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

Inactive ingredients

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

Questions or comments?

1-800-373-6981 (toll-free)

Distributed by:
Shield Pharmaceuticals Corp.
Hauppauge, NY 11788

PRINCIPAL DISPLAY PANEL

Heartburn Relief


Famotidine Tablets 10 mg
Acid Reducer


Just One Tablet!
Prevents and Relieves Heartburn Due to Acid Indigestion

Carton

Label

HEARTBURN RELIEF 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83059-0005
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize8mm
FlavorImprint Code V;21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83059-0005-51 in 1 PACKAGE01/16/2024
150 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21582201/16/2024
Labeler - Shield Pharmaceuticals Corp (118724924)

Revised: 4/2024
 
Shield Pharmaceuticals Corp