RANITIDINE- ranitidine hydrochloride tablet, film coated

Ranitidine by

Drug Labeling and Warnings

Ranitidine by is a Otc medication manufactured, distributed, or labeled by Aphena Pharma Solutions - Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Ranitidine 150 mg (as ranitidine hydrochloride, USP 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 any 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 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, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and vanillin

Questions or Comments?

Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time) 

Repackaging Information

Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

• Count: 150mg
• 180: 43353-952-80
• 1000: 43353-952-71

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:

Cookeville, TN 38506

20160602DH

Principal Display Panel

Maximum Strength

Ranitidine Tablets USP, 150 mg 180 & 1000 ct bottle

Acid Reducer

Prevents & Relieves

Heartburn Associated with Acid Indigestion & Sour Stomach

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

PRINCIPAL DISPLAY PANEL - 150mg

NDC: 43353-952 - Ranitidine HCl 150mg - Rx Only

INGREDIENTS AND APPEARANCE

RANITIDINE 
ranitidine hydrochloride tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43353-952(NDC:60505-2880)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ranitidine Hydrochloride (UNII: BK76465IHM) (ranitidine - UNII:884KT10YB7)	ranitidine	150 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	ROUND	Size	9mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43353-952-80	180 in 1 BOTTLE; Type 0: Not a Combination Product	06/26/2014
2	NDC: 43353-952-71	1000 in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA200172	07/15/2013

Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)

Establishment
Name	Address	ID/FEI	Business Operations
Aphena Pharma Solutions - Tennessee, LLC		128385585	REPACK(43353-952)