Your browser does not support JavaScript! RANITIDINE TABLET [FRED'S INC.]
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RxNorm Names

RANITIDINE tablet
[Fred's Inc.]


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

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 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 foods and beverages

WARNINGS

Allergy alert: Do not use if you are allergic to ranitidine 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
  • if you have kidney disease, except under the advice and supervision of a 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
    • to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause heartburn
    • can be used up to twice daily (do not take more than 2 tablets in 24 hours)
  • children under 12 years: ask a doctor

OTHER INFORMATION

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN.
  • store at 20° - 25° C (68° - 77° F)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

INACTIVE INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

fred's®

Maximum Strength

Ranitidine Tablets, USP

150 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

50 TABLETS

Compare To the active ingredient of Zantac 150®

DISTRIBUTED BY: fred's, Inc.

5092927/0112

This is the 50 count bottle carton label for Fred's Ranitidine tablets USP, 150mg.
RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55315-351
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
COLLOIDAL SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (Off-White to Pale Yellow) Scoreno score
ShapeOVALSize7mm
FlavorImprint Code 9R
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-351-5050 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20053603/30/2012
Labeler - Fred's Inc. (005866116)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829manufacture(55315-351)

Revised: 1/2013
 
Fred's Inc.

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