RANITIDINE- ranitidine tablet, coated 
Sam's West Inc

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Drug Facts

Active ingredient (in each tablet)

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

Purpose

Acid reducer

Use(s)

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

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 are

• taking a prescription drug. Acid reducers may interactwith certain prescription drugs.

Stop use and ask 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

FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.

Questions?

Call 1-888-375-3784

Revised: 0419

Consumer Information

What you should know about

MAXIMUM STRENGTH

Ranitidine Tablets USP, 150 mg

(Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference.)

What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

Excellent Safety Record

What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent?

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How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg?

How does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work?

Tips for managing heartburn

Do not Use

When should I see a doctor?

• Ask a doctor before use if you have

Ask a doctor or pharmacist before use ifyou are

• taking a prescription drug. Acid reducersmay interact with certain prescription drugs.

• Stop use and ask a doctor if

Questions? Call 1-888-375-3784

BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.

BLISTERS: Do not use if the individual blister unit is open or torn.

Revised: 0419

SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. IMPORTANT:

Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information. 

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

Container Label:

Carton Label

Maximum Strength
Ranitidine Tablets USP,150 mg
ACID REDUCER


PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

190 Tablets(190 doses)

Carton


Bottle

Maximum Strength
Ranitidine Tablets USP,150 mg
ACID REDUCER


PREVENTS & RELIEVES
heartburn associated with acid indigestion
and sour stomach

95 Tablets(95 doses)

Bottle


RANITIDINE 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68196-985(NDC:55111-404)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ranitidine Hydrochloride (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
titanium dioxide (UNII: 15FIX9V2JP)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code R150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68196-985-192 in 1 CARTON01/05/201109/30/2019
195 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07819201/05/2011
Labeler - Sam's West Inc (051957769)

Revised: 12/2019
Document Id: a8d2a7e2-d0b6-465d-8fe0-369740fab30a
Set id: 36bd757d-f31a-b1fd-2372-fee11a264625
Version: 4
Effective Time: 20191209
 
Sam's West Inc