RANITIDINE- ranitidine hydrochloride tablet 
Medline Industries, Inc.

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Drug Facts

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)

PURPOSE

Acid reducer

USES

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

OTHER INFORMATION

INACTIVE INGREDIENTS

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

QUESTIONS?

Call 1-800-MEDLINE (633-5463), Monday - Friday, 9AM - 5PM CST

PRINCIPAL DISPLAY PANEL

MEDLINE

NDC 53329-695-68

Compare to the active ingredient of Zantac 150®

Maximum Strength

RANITIDINE TABLETS, USP 150 mg

ACID REDUCER

Prevents & Relieves

Heartburn Associated with Acid Indigestion & Sour Stomach

150 mg

24 TABLETS

Distributed by: Medline Industries, Inc.

5099014/1012

24's blister carton label
RANITIDINE 
ranitidine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53329-695
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:53329-695-6824 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20053603/30/2012
Labeler - Medline Industries, Inc. (025460908)
Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
NameAddressID/FEIBusiness Operations
Shasun Pharmaceuticals Limited915786829manufacture(53329-695)

Revised: 3/2013
Document Id: 92f91121-229b-4942-b6d6-3d969c23a8fa
Set id: 9b05deaa-4d46-452b-ab74-7bc0b1111bbb
Version: 1
Effective Time: 20130326
 
Medline Industries, Inc.