RANITIDINE- ranitidine hydrochloride tablet, film coated

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Apotex Corp., Apotex Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ranitidine 75 mg (as ranitidine hydrochloride, USP 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
• kidney disease

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

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 seal under bottle cap is broken or torn
• store at 20°C to 25°C (68°F to 77°F)
• avoid excessive heat or humidity
• this product is sodium and sugar free

Inactive ingredients

carnauba wax, colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, titanium dioxide, vanillin, red and yellow ferric oxide

Questions?

Call 1-800-706-5575

Principal Display Panel- Bottle Carton - 75 mg 30 Tablets

Regular Strength

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Apotex Corp. Weston, Florida 33326, USA.

Principal Display Panel- Blister Carton - 75 mg 30 Tablets

Regular Strength

Ranitidine Tablets USP, 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Distributed by: Apotex Corp. Weston, Florida 33326, USA.

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60505-2881
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
Carnauba Wax (UNII: R12CBM0EIZ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Hypromelloses (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
Titanium Dioxide (UNII: 15FIX9V2JP)
Vanillin (UNII: CHI530446X)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	PENTAGON (5 sided)	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60505-2881-3	1 in 1 CARTON	01/24/2005
1		30 in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 60505-2881-8	1 in 1 CARTON	01/24/2005
2		80 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 60505-2881-7	1 in 1 CARTON	01/24/2005
3		1000 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075167	01/24/2005

RANITIDINE 
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60505-0160
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
Carnauba Wax (UNII: R12CBM0EIZ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Hypromelloses (UNII: 3NXW29V3WO)
Magnesium Stearate (UNII: 70097M6I30)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Polydextrose (UNII: VH2XOU12IE)
Titanium Dioxide (UNII: 15FIX9V2JP)
Vanillin (UNII: CHI530446X)
Ferric Oxide Red (UNII: 1K09F3G675)
Ferric Oxide Yellow (UNII: EX438O2MRT)

Product Characteristics
Color	PINK	Score	no score
Shape	PENTAGON (5 sided)	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60505-0160-3	1 in 1 CARTON	12/22/2016
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 60505-0160-4	3 in 1 CARTON	12/22/2016
2		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA075167	12/22/2016

Labeler - Apotex Corp. (845263701)

Registrant - Apotex Inc. (209429182)

Establishment
Name	Address	ID/FEI	Business Operations
Apotex Inc.		209429182	manufacture(60505-2881, 60505-0160) , analysis(60505-2881, 60505-0160)