ZANTAC 150 MAXIMUM STRENGTH- ranitidine hydrochloride tablet 
Chattem, Inc.

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Zantac 150

Zantac 150®

Drug Facts

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride 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

  • 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
  • store at 20-25°C (68-77°F)
  • 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 1-800-633-1610 or visit www.zantacotc.com

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

PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH
Zantac 150
Ranitidine 150 mg/ Acid reducer
90 TABLETS
(90 DOSES)

PRINCIPAL DISPLAY PANEL MAXIMUM STRENGTH Zantac 150 Ranitidine 150 mg/ Acid reducer 90 TABLETS (90 DOSES)

ZANTAC 150  MAXIMUM STRENGTH
ranitidine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE150 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (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:41167-0310-11 in 1 CARTON10/12/201810/18/2019
13 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0310-21 in 1 CARTON08/17/201810/18/2019
28 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0310-33 in 1 CARTON08/17/201810/18/2019
38 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-0310-71 in 1 CARTON04/03/201810/18/2019
440 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41167-0310-41 in 1 CARTON04/03/201810/18/2019
550 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:41167-0310-51 in 1 CARTON04/03/201810/18/2019
665 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
7NDC:41167-0310-82 in 1 CARTON04/03/201810/18/2019
760 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
8NDC:41167-0310-91 in 1 CARTON04/03/201810/18/2019
878 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
9NDC:41167-0310-61 in 1 CARTON04/03/201810/18/2019
990 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
10NDC:41167-0310-01 in 1 CARTON11/11/201810/18/2019
101 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02169804/03/201810/18/2019
Labeler - Chattem, Inc. (003336013)

Revised: 4/2018
Document Id: 7dfde990-4bbd-4f3b-8fbf-1cdf164223cf
Set id: 78380bf5-7ab6-42da-a02c-24644db778ff
Version: 5
Effective Time: 20180403
 
Chattem, Inc.