MAXIMUM STRENGTH ZANTAC- ranitidine tablet, coated 
Boehringer Ingelheim Pharmaceuticals Inc.

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Zantac 150® Drug Facts

Drug Facts

Active ingredient (in each tablet)Purpose
Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)......................................................................................................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

  • 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

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.

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

  • do not use if printed foil under bottle cap is open or torn (bottles)
  • do not use if individual blister unit is open or torn (blisters)
  • do not use if individual foil packet is open or torn (pouch)
  • store at 20º-25ºC (68º-77ºF)
  • avoid excessive heat or humidity
  • this product is sodium and sugar free

Inactive ingredients

hypromellose, magnesium stearate, microcrystalline cellulose, synthetic red iron oxide, titanium dioxide, triacetin

Questions?

Call 1-888-285-9159 (English/Spanish) M – F, 8:30 – 5 EST, or visit www.zantacotc.com

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

Boehringer Ingelheim Consumer Health Care Products
Division of Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877
Copyright © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
Product of Spain. Manufactured in Mexico.

Zantac 150 mg - 24 Count Blister Carton

Zantac 150 24 Count Blister Carton

Zantac 150 mg - 65 Count Bottle Carton

Zantac 150 65 Count Bottle Carton
MAXIMUM STRENGTH ZANTAC 
ranitidine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0121
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ranitidine hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7) ranitidine150 mg
Inactive Ingredients
Ingredient NameStrength
hypromelloses (UNII: 3NXW29V3WO)  
magnesium stearate (UNII: 70097M6I30)  
cellulose, microcrystalline (UNII: OP1R32D61U)  
ferric oxide red (UNII: 1K09F3G675)  
titanium dioxide (UNII: 15FIX9V2JP)  
triacetin (UNII: XHX3C3X673)  
Product Characteristics
ColorPINK (Dark Pink) Scoreno score
ShapePENTAGON (5 sided)Size4mm
FlavorImprint Code Z;150
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0121-061 in 1 CARTON12/21/200610/18/2019
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:0597-0121-501 in 1 CARTON12/21/200610/18/2019
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:0597-0121-081 in 1 POUCH; Type 0: Not a Combination Product12/21/200610/18/2019
4NDC:0597-0121-094 in 1 CARTON12/21/200610/18/2019
48 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:0597-0121-243 in 1 CARTON12/21/200610/18/2019
58 in 1 BLISTER PACK; Type 0: Not a Combination Product
6NDC:0597-0121-381 in 1 CARTON12/21/200610/18/2019
68 in 1 BLISTER PACK; Type 0: Not a Combination Product
7NDC:0597-0121-641 in 1 CARTON12/21/200610/18/2019
765 in 1 BOTTLE; Type 0: Not a Combination Product
8NDC:0597-0121-681 in 1 CARTON12/21/200610/18/2019
865 in 1 BOTTLE; Type 0: Not a Combination Product
9NDC:0597-0121-8080 in 1 CARTON12/21/200610/18/2019
91 in 1 POUCH; Type 0: Not a Combination Product
10NDC:0597-0121-8280 in 1 CARTON12/21/200610/18/2019
101 in 1 POUCH; Type 0: Not a Combination Product
11NDC:0597-0121-941 in 1 CARTON12/21/200610/18/2019
1145 in 1 BOTTLE; Type 0: Not a Combination Product
12NDC:0597-0121-902 in 1 CARTON12/21/200610/18/2019
1245 in 1 BOTTLE; Type 0: Not a Combination Product
13NDC:0597-0121-851 in 1 CARTON12/21/200610/18/2019
1385 in 1 BOTTLE; Type 0: Not a Combination Product
14NDC:0597-0121-012 in 1 CARTON12/21/200610/18/2019
1450 in 1 BOTTLE; Type 0: Not a Combination Product
15NDC:0597-0121-781 in 1 CARTON12/21/200610/18/2019
1578 in 1 BOTTLE; Type 0: Not a Combination Product
16NDC:0597-0121-661 in 1 CARTON12/21/200610/18/2019
1640 in 1 BOTTLE; Type 0: Not a Combination Product
17NDC:0597-0121-112 in 1 CARTON12/21/200610/18/2019
1760 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02169812/21/200610/18/2019
Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
Patheon Manufacturing Services LLC079415560MANUFACTURE(0597-0121)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Promeco S.A de C.V.812579472LABEL(0597-0121) , ANALYSIS(0597-0121) , MANUFACTURE(0597-0121) , PACK(0597-0121)

Revised: 5/2021
 
Boehringer Ingelheim Pharmaceuticals Inc.