Heartburn Relief

Heartburn Relief
SPL v4
SPL
SPL Set ID a12ec91d-244f-45c5-8590-d1e4485fe361
Route
ORAL
Published
Effective Date 2024-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Carnauba Wax Hypromelloses Hydroxypropyl Cellulose, Unspecified Magnesium Stearate Microcrystalline Cellulose Starch, Corn Sodium Starch Glycolate Type A Corn Talc Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: T;10 Shape: round Color: white Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2024-06-11

Description

Drug Facts

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50566-9

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Section 50568-5

Ask a doctor or pharmacist before use if you aretaking

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

Section 50569-3

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
Section 50570-1

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
Section 53414-9

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

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
Warnings

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

Directions

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)

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

carnauba wax, corn starch, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments?

1-800-373-6981 (toll-free)

Principal Display Panel

Heartburn Relief



Famotidine Tablets USP 10 mg

Acid Reducer



Just One Tablet!

Prevents and Relieves Heartburn Due to Acid Indigestion

Active Ingredient (in Each Liquid Filled Capsule)

Famotidine 10 mg


Structured Label Content

Section 42229-5 (42229-5)

Drug Facts

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • your heartburn continues or worsens
  • you need to take this product for more than 14 days

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you aretaking

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

Section 50569-3 (50569-3)

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
Section 50570-1 (50570-1)

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
Section 53414-9 (53414-9)

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

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 food and beverages
Warnings

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

Directions

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)

Other Information (Other information)
  • read the directions and warnings before use
  • keep the carton. It contains important information.
  • 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, sodium starch glycolate, talc, titanium dioxide.

Questions Or Comments? (Questions or comments?)

1-800-373-6981 (toll-free)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Heartburn Relief



Famotidine Tablets USP 10 mg

Acid Reducer



Just One Tablet!

Prevents and Relieves Heartburn Due to Acid Indigestion

Active Ingredient (in Each Liquid Filled Capsule) (Active ingredient (in each liquid-filled capsule))

Famotidine 10 mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)