Zantac 360°™, Lil Drug Store, Zantac 360°™, Travel Basix

Zantac 360°™, Lil Drug Store, Zantac 360°™, Travel Basix
SPL v3
SPL
SPL Set ID ea38535a-c9db-d03f-e053-2a95a90adf2d
Route
ORAL
Published
Effective Date 2022-10-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Magnesium Stearate Talc Ferric Oxide Yellow Hypromellose 2910 (5 Mpa.s) Sodium Starch Glycolate Type A Corn Carnauba Wax Cellulose, Microcrystalline Hydroxypropyl Cellulose (1600000 Wamw) Starch, Corn Titanium Dioxide Ferric Oxide Red

Identifiers & Packaging

Pill Appearance
Imprint: CC;59 Shape: square Color: yellow Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2022-10-11

Description

Active ingredient (in each tablet) Famotidine USP 20 mg

Purpose

Purpose Acid reducer


Medication Information

Purpose

Purpose

Acid reducer

Description

Active ingredient (in each tablet) Famotidine USP 20 mg

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
Section 42229-5

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

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 53414-9

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

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
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
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]

Alergy Alert

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

Active Ingredient

Active ingredient (in each tablet)

Famotidine USP 20 mg

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

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
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
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.

Zantac 360°™, Travel Basix

NEW FORMULA

See New Warnings

MAXIMUM STRENGTH

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

[Travel BASIX logo]

Zantac 360°™, Lil' Drug Store ®

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]


Structured Label Content

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
Section 42229-5 (42229-5)

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

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 53414-9 (53414-9)

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

Purpose

Purpose

Acid reducer

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
Do Not Use (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
Pdp/package (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]

Alergy Alert (Alergy alert)

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

Active Ingredient

Active ingredient (in each tablet)

Famotidine USP 20 mg

Other Information (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)

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?)

Questions or comments?

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

Ask A Doctor Before Use (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
Stop Use and Ask A Doctor (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
Ask A Doctor Or Pharmacist (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.

Zantac 360°™, Travel Basix (Zantac 360°™, Travel BASIX)

NEW FORMULA

See New Warnings

MAXIMUM STRENGTH

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

[Travel BASIX logo]

Zantac 360°™, Lil' Drug Store ®

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]


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)