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| Product NDC Code | 62207-773 | ||||||||||
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| 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 | ||||||||||
| RxCUI drug identifier | 198191 | ||||||||||
| Application Number | ANDA210243 | ||||||||||
| Labeler Name | Granules India Ltd | ||||||||||
| Packages |
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| 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(S) Ranitidine 150 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) ◾ do not chew tablet (for cool mint tablets only) ◾ children under 12 years: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS For 150 mg: croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol,talcum, titanium dioxide For 150 mg cool mint: acacia, croscarmellose sodium, FD&C Blue No. 1,magnesium stearate, menthol, microcrystalline cellulose,polyethylene glycol, polyvinyl alcohol, talcum, 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 CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FERRIC OXIDE RED MAGNESIUM STEARATE POLYETHYLENE GLYCOL POLYVINYL ALCOHOL TALC TITANIUM DIOXIDE RANITIDINE HYDROCHLORIDE RANITIDINE 150;G Ranitidine cool mint Ranitidine ACACIA CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 MAGNESIUM STEARATE MENTHOL POLYETHYLENE GLYCOL POLYVINYL ALCOHOL TALC TITANIUM DIOXIDE RANITIDINE HYDROCHLORIDE RANITIDINE 150;G
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.PRINCIPAL DISPLAY PANEL 62207-774-58-carton.jpg 62207-774-47-carton.jpg 62207-774-41-carton.jpg 62207-773-58-carton.jpg 62207-773-47-carton.jpg 62207-773-41-carton.jpg ranitidine-label4-jpg ranitidine-label3-jpg ranitidine-150mg-label2-jpg ranitidine-150mg-label1-jpg 62207-774-32.jpg 62207-773-32.jpg 62207-774-336.jpg 62207-773-36-carton.jpg
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 individual blister unit is open or torn. ◾ do not use if printed foil under bottle cap is open or torn ◾ store at 20 0 -25 0 C (68 0 -77 0 F) ◾ avoid excessive heat or humidity ◾ this product is sodium and sugar free
Questions or comments? •Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM EST. This product is not manufactured or distributed by Boehringer Ingelheim ® consumer health care products, distributor of Zantac 150mg and 150mg Cool Mint
Read the directions and warnings before use. Keep the carton. It contains important information including tips for managing heartburn. 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 andfried 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
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 ◾ 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 ◾ kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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
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.
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 feedingPREGNANCY/BREASTFEEDING 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
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