Zantac 360, 2 Tablet Per Blister, 6 Blisters

Zantac 360, 2 Tablet Per Blister, 6 Blisters
SPL v1
SPL
SPL Set ID fd61a2d6-5c8a-4e7a-8b19-37406b90f778
Route
ORAL
Published
Effective Date 2022-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Carnauba Wax Starch, Corn Hydroxypropyl Cellulose, Unspecified Hypromellose, Unspecified Magnesium Stearate Microcrystalline Cellulose Ferric Oxide Red Sodium Starch Glycolate Type A Talc Titanium Dioxide Ferric Oxide Yellow

Identifiers & Packaging

Pill Appearance
Imprint: CC;59 Shape: round Color: yellow Size: 5 mm Score: 1
Marketing Status
ANDA Active Since 2021-10-01

Description

Famotidine USP 20mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Famotidine USP 20mg

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Warnings

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

Directions
  • adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet with a glass or 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
Drug Facts

Other Information
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°25°C (68°F-77°F)
  • protect from moisture
Package Labeling:

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
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 (1-800-222-1222) right away.

Active Ingredient (in Each Tablet)

Famotidine USP 20mg

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 or 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.


Structured Label Content

Uses
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevent heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages
Purpose

Acid reducer

Warnings

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

Directions
  • adults and children 12 years and over:
  • to relieve symptoms, swallow 1 tablet with a glass or 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
Drug Facts

Other Information (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • store at 20°25°C (68°F-77°F)
  • protect from moisture
Package Labeling:

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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Famotidine USP 20mg

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 or 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 (Ask a doctor or pharmacist before use if you are)

taking a prescription drug. Acid reducers may interact with certain prescription drugs.


Advanced Ingredient Data


Raw Label Data

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