ZANTAC 75 REGULAR STRENGTH- ranitidine hydrochloride tablet, coated 
Chattem, Inc.

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Zantac 75

Zantac 75®

Drug Facts

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride 84 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

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)
    ▪ do not chew tablet
  • 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, 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

Regular Strength
Zantac
75
Ranitidine 75 mg/ Acid reducer
80 TABLETS (80 DOSES)

PRINCIPAL DISPLAY PANEL
Regular Strength
Zantac
75
Ranitidine 75 mg/ Acid reducer
80 TABLETS (80 DOSES)

ZANTAC 75  REGULAR STRENGTH
ranitidine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-0300
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7) RANITIDINE75 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE, UNSPECIFIED (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)Size3mm
FlavorImprint Code Z;75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-0300-21 in 1 CARTON10/12/201810/18/2019
14 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:41167-0300-31 in 1 CARTON08/17/201810/18/2019
210 in 1 BLISTER PACK; Type 0: Not a Combination Product
3NDC:41167-0300-53 in 1 CARTON08/17/201810/18/2019
310 in 1 BLISTER PACK; Type 0: Not a Combination Product
4NDC:41167-0300-61 in 1 CARTON04/03/201810/18/2019
460 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5NDC:41167-0300-71 in 1 CARTON04/03/201810/18/2019
580 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6NDC:41167-0300-01 in 1 CARTON11/26/201810/18/2019
61 in 1 POUCH; Type 0: Not a Combination Product
7NDC:41167-0300-11 in 1 CARTON04/03/201810/18/2019
72 in 1 POUCH; Type 0: Not a Combination Product
8NDC:41167-0300-8100 in 1 CONTAINER04/03/201810/18/2019
81 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02052004/03/201810/18/2019
Labeler - Chattem, Inc. (003336013)

Revised: 4/2018
 
Chattem, Inc.