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| Product NDC Code | 71713-203 | ||
|---|---|---|---|
| Drug Name | Ranitidine |
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| Type | Generic | ||
| Pharm Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
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| Active Ingredients |
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| Route | ORAL | ||
| Dosage Form | TABLET, COATED | ||
| RxCUI drug identifier | 198191 | ||
| Application Number | ANDA078192 | ||
| Labeler Name | Thirty Madison Inc | ||
| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Ranitidine 150 mg (as ranitidine hydrochloride USP, 168 mg)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients FD&C red #40 aluminum lake, hypromellose, iron oxide black, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Use(s) 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
Purpose
Information about the drug product’s indications for use.Purpose Acid reducer
Spl product data elements
Usually a list of ingredients in a drug product.Ranitidine Ranitidine Ranitidine Hydrochloride RANITIDINE FD&C RED NO. 40 HYPROMELLOSE 2910 (6 MPA.S) FERROSOFERRIC OXIDE magnesium stearate cellulose, microcrystalline POLYETHYLENE GLYCOL 400 titanium dioxide R150 Carton Bottle
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Bottle Label
Carton label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.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 protect from light this product is sodium and sugar free
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.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
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1-888-375-3784
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask doctor if your heartburn continues or worsens you need to take this product for more than 14 days
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API