OTC Medication Information: Ranitidine

RANITIDINE- ranitidine hydrochloride tablet, film coated
Aphena Pharma Solutions — Tennessee, LLC

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:

Count150mg
18043353-952-80
100043353-952-71

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:
Aphena Pharma Solutions -- TN
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

Bottle Label 150mg
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ranitidine Hydrochloride (ranitidine) ranitidine 150 mg
Inactive Ingredients
Ingredient Name Strength
Carnauba Wax
Silicon Dioxide
Hypromelloses
Magnesium Stearate
Cellulose, Microcrystalline
Polydextrose
Titanium Dioxide
Vanillin
Ferric Oxide Red
Ferric Oxide Yellow
Product Characteristics
Color PINK Score no score
Shape ROUND Size 9mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43353-952-80 180 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:43353-952-71 1000 TABLET, FILM COATED in 1 BOTTLE None
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 Operations
Aphena Pharma Solutions — Tennessee, LLC 128385585 REPACK (43353-952)

Revised: 06/2016 Aphena Pharma Solutions — Tennessee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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