Your browser does not support JavaScript! FAMOTIDINE TABLET, FILM COATED [FRED'S INC.]
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RxNorm Names

FAMOTIDINE tablet, film coated
[Fred's Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

ACTIVE INGREDIENT (IN EACH TABLET)

Famotidine USP, 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

  • with other acid reducers
  • 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.

Ask a doctor before use if you have

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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 relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
    • to prevent symptoms, swallow 1 tablet with a glass of water 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

  • store at 20° to 25°C (68° to 77°F)
  • protect from moisture
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN.

INACTIVE INGREDIENTS

Colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PATIENT INFORMATION

  • 1 tablet relieves heartburn due to acid indigestion
  • Famotidine prevents 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

PRINCIPAL DISPLAY PANEL

fred's®

Original Strength

Acid Controller

Famotidine Tablets USP, 10 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn Due to Acid Indigestion

30 TABLETS

Compare To Original Strength Pepcid®AC

DISTRIBUTED BY: fred's, Inc.

5092839/R0112

This is the 30 count blister carton label for Fred's Famotidine tablets USP, 10 mg.
FAMOTIDINE 
famotidine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-035
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE10 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
HYDROXYPROPYL CELLULOSE 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
STARCH, PREGELATINIZED CORN 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeROUNDSize8mm
FlavorImprint Code 035
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-035-3130 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09028306/25/2010
Labeler - Fred's Inc. (005866116)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029manufacture(55315-035)

Revised: 1/2013
 
Fred's Inc.

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