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Zantac 360
Famotidine · Tablet, Film Coated
Overview
Active ingredients
Source: NDC Directory| Ingredient | Strength | RxCUI | Monograph |
|---|---|---|---|
| Famotidine | 20 mg/1 | 283641 | View |
Forms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Histamine H2 Receptor Antagonists [MoA] | MoA | All 48 members |
| Histamine-2 Receptor Antagonist [EPC] | EPC | All 48 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206531-001 | FAMOTIDINE | TABLET | FAMOTIDINE | Over-the-counter | — | ||
| 206531-002 | FAMOTIDINE | TABLET | FAMOTIDINE | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 18 | Labeling | Approved | August 25, 2022 | Standard |
| Supplement | 17 | Manufacturing (CMC) | Approved | July 15, 2022 | Unknown |
| Supplement | 7 | Labeling | Approved | September 11, 2019 | Standard |
| Supplement | 1 | Labeling | Approved | September 11, 2019 | Standard |
| Original application | 1 | Approved | April 26, 2016 | Standard |
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260627). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse 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
Uses ■ 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
Purpose
openFDA Drug LabelingPurpose Acid reducer
Purpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDirections ■ 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
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 1 0 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
openFDA Drug LabelingWarnings 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)
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 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 ■ 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)
Do Not Use
openFDA Drug LabelingDo 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
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
openFDA Drug LabelingAsk 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 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 ■ kidney disease
Stop Use
openFDA Drug LabelingStop use and ask a doctor if ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days
Stop use and ask a doctor if ■ your heartburn continues or worsens ■ you need to take this product for more than 14 days
Active Ingredient
openFDA Drug LabelingActive i ngredient (in each tablet ) Famotidine USP 10 mg
Active ingredient (in each tablet) Famotidine USP 20 mg
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: FAMOTIDINE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.
Packaging and NDCs
Source: NDC Directory| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 41167-0361-0 | 41167-0361 | Chattem, Inc. | 1 BLISTER PACK in 1 CARTON (41167-0361-0) / 8 TABLET, FILM COATED in 1 BLISTER PACK | April 12, 2021 |
| 41167-0361-1 | 41167-0361 | Chattem, Inc. | 1 BLISTER PACK in 1 CARTON (41167-0361-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK | April 12, 2021 |
| 41167-0361-2 | 41167-0361 | Chattem, Inc. | 1 BOTTLE in 1 CARTON (41167-0361-2) / 25 TABLET, FILM COATED in 1 BOTTLE | April 12, 2021 |
| 41167-0361-4 | 41167-0361 | Chattem, Inc. | 1 BOTTLE in 1 CARTON (41167-0361-4) / 50 TABLET, FILM COATED in 1 BOTTLE | April 12, 2021 |
| 41167-0361-6 | 41167-0361 | Chattem, Inc. | 1 BOTTLE in 1 CARTON (41167-0361-6) / 90 TABLET, FILM COATED in 1 BOTTLE | April 12, 2021 |
| 41167-0361-8 | 41167-0361 | Chattem, Inc. | 1 BOTTLE in 1 CARTON (41167-0361-8) / 100 TABLET, FILM COATED in 1 BOTTLE | April 12, 2021 |
| 41167-0361-9 | 41167-0361 | Chattem, Inc. | 2 BOTTLE in 1 CELLO PACK (41167-0361-9) / 70 TABLET, FILM COATED in 1 BOTTLE | April 12, 2021 |
| 66715-9758-2 | 66715-9758 | Lil' Drug Store Products, Inc | 1 BLISTER PACK in 1 CARTON (66715-9758-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK | January 5, 2023 |
| 66715-9758-5 | 66715-9758 | Lil' Drug Store Products, Inc | 1 BLISTER PACK in 1 CARTON (66715-9758-5) / 5 TABLET, FILM COATED in 1 BLISTER PACK | September 20, 2021 |
| 67751-214-01 | 67751-214 | Navajo Manufacturing Company Inc. | 1 BLISTER PACK in 1 CARTON (67751-214-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK | August 1, 2022 |
| 67751-214-02 | 67751-214 | Navajo Manufacturing Company Inc. | 2 BLISTER PACK in 1 CARTON (67751-214-02) / 1 TABLET, FILM COATED in 1 BLISTER PACK | August 1, 2022 |
| 85237-1926-1 | 85237-1926 | Select Consumer Group LLC | 1 BLISTER PACK in 1 CONTAINER (85237-1926-1) / 1 TABLET, FILM COATED in 1 BLISTER PACK (85237-1926-0) | June 4, 2025 |
| 85237-1926-2 | 85237-1926 | Select Consumer Group LLC | 2 BLISTER PACK in 1 CONTAINER (85237-1926-2) / 1 TABLET, FILM COATED in 1 BLISTER PACK (85237-1926-0) | June 4, 2025 |
| 41167-0361 | 41167-0361 | Chattem, Inc. | — | April 12, 2021 |
| 66715-9758 | 66715-9758 | Lil' Drug Store Products, Inc | — | September 20, 2021 |
| 67751-214 | 67751-214 | Navajo Manufacturing Company Inc. | — | August 1, 2022 |
| 85237-1926 | 85237-1926 | Select Consumer Group LLC | — | April 12, 2021 |
Sources for this page
| Dataset | Agency | Used for |
|---|---|---|
| NDC Directory | FDA | Identity, ingredients, strengths, forms, routes, labelers, packages |
| Drugs@FDA | FDA | Application, sponsor, submissions, review documents, marketing status |
| Drug Labeling | FDA / NLM | Prescribing information reproduced above |
| FAERS | FDA | Adverse event report counts |
Generated September 25, 2026 · 10 sections on this page.