Zantac 360°™ - DailyMed Details

Zantac 360°™

SPL v1

SPL

SPL Set ID 228b4c42-eef3-45c9-b48d-cbfb9d816c54

Route

ORAL

Published

Effective Date 2022-04-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Famotidine (10 mg)

Inactive Ingredients

Carnauba Wax Starch, Corn Magnesium Stearate Microcrystalline Cellulose Ferric Oxide Red Talc Titanium Dioxide Hydroxypropyl Cellulose (1600000 Wamw) Sodium Starch Glycolate Type A Corn Hypromellose 2910 (5 Mpa.s)

Identifiers & Packaging

Pill Appearance

Imprint: CC;58 Shape: round Color: pink Size: 5 mm Score: 1

Marketing Status

ANDA Active Since 2021-04-12

Description

Drug Facts

Purpose

Acid reducer

Medication Information

Purpose

Acid reducer

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1

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).

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

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 10 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

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

Allergy Alert

Do not use if you are allergic to famotidine or other acid reducers

Other Information

read the directions and warnings before use
store at 20-25°C (68-77°F)
protect from moisture

Inactive Ingredients

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

Questions Or Comments?

call 1-800-633-1610 or visit www.zantacotc.com

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 (in Each Tablet)

Famotidine USP 20 mg

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

Principal Display Panel 1 Tablet Pouch Blister Pack

NEW FORMULA

MAXIMUM STRENGTH

See New Warnings

Zantac

360°_™

Famotidine Tablets USP 20 mg/Acid Reducer

JUST ONE TABLET

PREVENTS

& RELIEVES

HEARTBURN

DUE TO ACID

INDIGESTION

1 TABLET

Actual Size

2111926095.A

Structured Label Content

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Acid reducer

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 10 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

Do Not Use (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

Allergy Alert

Do not use if you are allergic to famotidine or other acid reducers

Other Information (Other information)

read the directions and warnings before use
store at 20-25°C (68-77°F)
protect from moisture

Inactive Ingredients (Inactive ingredients)

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide

Questions Or Comments? (Questions or Comments?)

call 1-800-633-1610 or visit www.zantacotc.com

Stop Use and Ask A Doctor If (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 (in Each Tablet) (Active ingredient (in each tablet))

Famotidine USP 20 mg

Ask A Doctor Before Use If You Have (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

Principal Display Panel 1 Tablet Pouch Blister Pack (PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack)

NEW FORMULA

MAXIMUM STRENGTH

See New Warnings

Zantac

360°_™

Famotidine Tablets USP 20 mg/Acid Reducer

JUST ONE TABLET

PREVENTS

& RELIEVES

HEARTBURN

DUE TO ACID

INDIGESTION

1 TABLET

Actual Size

2111926095.A

Advanced Ingredient Data

[{"name": "famotidine", "unii": "5QZO15J2Z8", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "carnauba wax", "unii": "R12CBM0EIZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "magnesium stearate", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "microcrystalline cellulose", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ferric oxide red", "unii": "1K09F3G675", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "talc", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "titanium dioxide", "unii": "15FIX9V2JP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "hydroxypropyl cellulose (1600000 WAMW)", "unii": "RFW2ET671P", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A CORN", "unii": "AG9B65PV6B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "hypromellose 2910 (5 mpa.s)", "unii": "R75537T0T4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Drug Facts", "50565-1": "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).", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Acid reducer", "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 10 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", "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", "Allergy Alert": "Do not use if you are allergic to famotidine or other acid reducers", "Other information": "read the directions and warnings before use store at 20-25°C (68-77°F) protect from moisture", "Inactive ingredients": "carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, red iron oxide, sodium starch glycolate, talc, titanium dioxide, yellow iron oxide", "Questions or Comments?": "call 1-800-633-1610 or visit www.zantacotc.com", "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 (in each tablet)": "Famotidine USP 20 mg", "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", "PRINCIPAL DISPLAY PANEL - 1 Tablet Pouch Blister Pack": "NEW FORMULA MAXIMUM STRENGTH See New Warnings Zantac 360° ™ Famotidine Tablets USP 20 mg/Acid Reducer JUST ONE TABLET PREVENTS & RELIEVES HEARTBURN DUE TO ACID INDIGESTION 1 TABLET Actual Size 2111926095.A"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:11.395653 · Updated: 2026-03-14T23:00:33.718954