ZANTAC 360- famotidine tablet, film-coated tablet, film coated

Zantac 360 by

Drug Labeling and Warnings

Zantac 360 by is a Otc medication manufactured, distributed, or labeled by Lil' Drug Store Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Active ingredient (in each tablet)
Famotidine USP 20 mg

Purpose

Purpose

Acid reducer

Uses

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 foods and beverages

Warnings

Alergy alert

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

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

Ask a doctor before use

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

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

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 healthcare 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).

Directions

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

Other information

Other information

• read the directions and warnings before use
• keep the carton. It contains important information.
• store at 20º-25ºC (68º-77ºF)
• 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

SPL UNCLASSIFIED SECTION

Product manufactured for:
Chattem, Inc., a Sanofi Company
P.O. Box 2219
Chattanooga, TN 37409-0219
©2021 Made in India

Product repackaged and distributed by:
Lil' Drug Store Products, Inc.
9300 Earhart Lane SW, Cedar Rapids, IA 52404
1-877-507-6516 (M-F 8AM-4:30PM CST)
www.lildrugstore.com 97585C-US-04-21

PDP/Package

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

[tablet image]

Actual Size

5 Tablets

(5 Doses)

[Lil' Drug Store logo]

Zantac 360°™, Lil' Drug Store ® - PDP/Package

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

[tablet image]

Actual Size

2 Tablets

(2 Doses)

[Lil' Drug Store logo]

INGREDIENTS AND APPEARANCE

ZANTAC 360 
famotidine tablet, film-coated tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66715-9758
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FAMOTIDINE (UNII: 5QZO15J2Z8) (FAMOTIDINE - UNII:5QZO15J2Z8)	FAMOTIDINE	20 mg

Inactive Ingredients
Ingredient Name	Strength
MAGNESIUM STEARATE (UNII: 70097M6I30)
TALC (UNII: 7SEV7J4R1U)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
HYPROMELLOSE 2910 (5 MPA.S) (UNII: R75537T0T4)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Product Characteristics
Color	yellow	Score	no score
Shape	SQUARE (Rounded edges; biconvex)	Size	5mm
Flavor		Imprint Code	CC;59
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66715-9758-5	1 in 1 CARTON	09/20/2021
1		5 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 66715-9758-2	1 in 1 CARTON	01/05/2023
2		2 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA206531	09/20/2021

Labeler - Lil' Drug Store Products, Inc (093103646)