Ranitidine by Aphena Pharma Solutions - Tennessee, LLC
Dosage form: tablet, film coated
Ingredients: Ranitidine Hydrochloride 150mg
Labeler: Aphena Pharma Solutions - Tennessee, LLC
NDC Code: 43353-952
Ranitidine 150 mg (as ranitidine hydrochloride, USP 168 mg)
- 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
Allergy alert: Do not use if you are allergic to ranitidine or any other acid reducers
- 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
- 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
- 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.
In case of overdose, get medical help or contact a Poison Control Center right away.
- 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
- 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
carnauba wax, colloidal silicon dioxide, ferric oxide red, ferric oxide yellow, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide and vanillin
Call 1-800-706-5575 (Monday to Friday 8:30 a.m. – 5:00 p.m. Eastern Standard Time)
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:
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.
Ranitidine Tablets USP, 150 mg 180 & 1000 ct bottle
Prevents & Relieves
Heartburn Associated with Acid Indigestion & Sour Stomach
Distributed by: Apotex Corp. Weston, Florida 33326, USA.
ranitidine hydrochloride tablet, film coated
|Labeler - Aphena Pharma Solutions - Tennessee, LLC (128385585)|
|Aphena Pharma Solutions - Tennessee, LLC||128385585||REPACK(43353-952)|
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.