Zantac 360

FAMOTIDINE ORAL HUMAN OTC DRUG

Zantac 360 is an FDA drug label for the active ingredient FAMOTIDINE manufactured by Select Consumer Group LLC administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260627.

Generic name
FAMOTIDINE
Manufacturer
Select Consumer Group LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
85237-1926
Application
ANDA206531
Label effective
20260627

About this product

Zantac 360 is an FDA-registered drug product whose active ingredient is FAMOTIDINE. It is labelled by Select Consumer Group LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85237-1926, application ANDA206531, label effective 20260627. It is one of 95 FDA drug label records sharing the active ingredient FAMOTIDINE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing FAMOTIDINE are most often described in connection with: heartburn associated, acid indigestion, sour stomach, brought eating, drinking certain. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active i ngredient (in each tablet ) Famotidine USP 10 mgActive ingredient (in each tablet) Famotidine USP 20 mg

Indications & Usage

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 food and beverages

Dosage & Administration

Directions ■ adults and children 12 years and over: ■ to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew. ■ to prevent symptoms, swallow 1 tablet with a glass of water at any time from 15 to 60 minutes before eating food or drinking beverages that cause heartburn ■ do not use more than 2 tablets in 24 hours ■ children under 12 years: ask a doctor

Warnings

Warnings Allergy alert: Do not use if you are allergic to famotidine 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 Ask a doctor before us e 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 ■ kidney disease Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. 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. (1-800-222-1222)

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How products containing FAMOTIDINE compare

FDA lists 95 drug label records with FAMOTIDINE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Proficient Rx LP 10
— — A-S Medication Solutions 8
— — Preferred Pharmaceuticals Inc. 4
— — REMEDYREPACK INC. 4
— — Fresenius Kabi USA, LLC 3

Frequently asked questions

What is Zantac 360 used for?
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 food and beverages

Who makes Zantac 360?
Select Consumer Group LLC is the labeler of record for Zantac 360. 95 FDA label records share the active ingredient FAMOTIDINE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Zantac 360 come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Zantac 360 prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing FAMOTIDINE?
Yes. 95 FDA drug label records list FAMOTIDINE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Zantac 360 been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.