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| Product NDC Code | 30142-505 | ||
|---|---|---|---|
| Drug Name | Heratburn relief |
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| Type | Brand | ||
| 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 | The Kroger Co. | ||
| 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.Heratburn Relief 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 containercarton24 ContainerCarton50 figure
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.PACKAGE LABEL PRINCIPAL DISPLAY PANEL Container Carton:
Container Carton Label:
Blister 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
Consumer Information What you should know about MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg (Please read all of this information before taking MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg. Save this leaflet for future reference.) What are MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg contains 150 mg of ranitidine (as ranitidine hydrochloride USP, 168 mg), a medicine that doctors have prescribed more than 200 million times worldwide. Excellent Safety Record The ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg, ranitidine, has been prescribed by doctors for years to treat millions of patients safely and effectively. The active ingredient in MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg has been taken safely with many frequently prescribed medications. MAXIMUM STRENGTH Ranitidne Tablets USP, 150 mg are sodium and sugar free. What symptoms does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg relieve and prevent heartburn associated with acid Indigestion and sour stomach. Eating or drinking certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion and sour stomach. It is normal to the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort. How should I take MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg? 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. This medicine can be used up to twice daily (up to 2 tablets in 24 hours). Do not chew tablet. MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg should not be given to children under 12 years old unless directed by a doctor. Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers. How does MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg work? MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg reduce the production of stomach acid. This is what make MAXIMUM STRENGTH Ranitidine Tablets USP, 150 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid. Tips for managing heartburn Do not lie flat or bend over soon after eating Do not eat late at night, or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods chocolate, caffeine, alcohol, even some fruits and vegetables Eat slowly and do not eat big meals If you are overweight, lose weight If you smoke, quit smoking Raise the head of your bed Wear loose fitting clothing around your stomach When should I see a doctor? 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. heartbrun 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. Questions? Call 1-888-375-3784 BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn . BLISTERS: Do not use if the individual blister unit is open or torn.
Consumer Information
SEALED WITH PRINTED FOIL UNDER CAP FOR YOUR PROTECTION. IMPORTANT: Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
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.(1-800-222-1222)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions call 1-800-632-6900
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.(1-800-222-1222)
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