RANITIDINE 150- ranitidine hydrochloride tablets 150mg tablet, coated 
Allegiant Health

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375 - Health A2Z Acid Reducer 150mg

Active ingredient (in each tablet)

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

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 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 (1-800-222-1222) right away.

Directions

adults and children 12 years of age 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

  • do not use if the individual blister unit is open or torn
  • store at 20ºC to 25ºC (68ºF to 77ºF)
  • avoid excessive heat or humidity
  • protect from light
  • this product is sodium and sugar free

Inactive ingredients

carnauba wax, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, red and yellow 

ferric oxide, silicon dioxide, titanium dioxide, vanillin

Questions or comments?

1-888-952-0050 Monday through Friday 9AM-5PM EST

Principal Display Panel

Acid Reducer 150mg

Acid Reducer 150mg

RANITIDINE 150 
ranitidine hydrochloride tablets 150mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-375
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)  
VANILLIN (UNII: CHI530446X)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize9mm
FlavorImprint Code APO;150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-375-291 in 1 CARTON01/05/201009/30/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69168-375-932 in 1 CARTON01/05/201009/30/2020
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07819201/05/201009/30/2020
Labeler - Allegiant Health (079501930)
Establishment
NameAddressID/FEIBusiness Operations
Apotex Inc.205576023ANALYSIS(69168-375) , MANUFACTURE(69168-375)

Revised: 11/2017
 
Allegiant Health