ZANTAC 75 REGULAR STRENGTH- ranitidine hydrochloride tablet, coated

Zantac 75 by

Drug Labeling and Warnings

Zantac 75 by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

ZANTAC 75  REGULAR STRENGTH
ranitidine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-0300
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
RANITIDINE HYDROCHLORIDE (UNII: BK76465IHM) (RANITIDINE - UNII:884KT10YB7)	RANITIDINE	75 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	PINK (dark pink)	Score	no score
Shape	PENTAGON (5 SIDED)	Size	3mm
Flavor		Imprint Code	Z;75
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-0300-2	1 in 1 CARTON	10/12/2018
1		4 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 41167-0300-3	1 in 1 CARTON	08/17/2018
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
3	NDC: 41167-0300-5	3 in 1 CARTON	08/17/2018
3		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
4	NDC: 41167-0300-6	1 in 1 CARTON	04/03/2018
4		60 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
5	NDC: 41167-0300-7	1 in 1 CARTON	04/03/2018
5		80 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
6	NDC: 41167-0300-0	1 in 1 CARTON	11/26/2018
6		1 in 1 POUCH; Type 0: Not a Combination Product
7	NDC: 41167-0300-1	1 in 1 CARTON	04/03/2018
7		2 in 1 POUCH; Type 0: Not a Combination Product
8	NDC: 41167-0300-8	100 in 1 CONTAINER	04/03/2018
8		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020520	04/03/2018

Labeler - Chattem, Inc. (003336013)