SPL v2
SPL
SPL Set ID 33dc93a5-ee03-2e68-e063-6294a90aeee1
Route
ORAL
Published
Effective Date 2025-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (10 mg)
Inactive Ingredients
Talc Hydroxypropyl Cellulose, Unspecified Microcrystalline Cellulose 102 Sodium Starch Glycolate Type A Potato Starch, Corn Microcrystalline Cellulose 101 Hypromellose 2910 (5 Mpa.s) Hypromellose 2910 (15 Mpa.s) Titanium Dioxide Magnesium Stearate Carnauba Wax

Identifiers & Packaging

Pill Appearance
Imprint: T;10 Shape: round Color: white Size: 6 mm
Marketing Status
ANDA Active Since 2025-05-15

Description

Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight fitting clothing around th estomach Do not eat before bedtime Raise the head of your bed Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing Drug Facts


Medication Information

Warnings and Precautions

Alergy Alert

Do not us if allergic to Famotidine or other acid reducers

Indications and Usage
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages
Dosage and Administration

Directions

  • adults and children 12 years and over:
  • to relieve symtoms, 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 15 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

Description

Tips for Managing Heartburn Do not lie flat or bend over after eating Do not wear tight fitting clothing around th estomach Do not eat before bedtime Raise the head of your bed Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing Drug Facts

Section 42229-5

Tips for Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight fitting clothing around th estomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables

Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages

Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing

Drug Facts

Section 44425-7

Other Information

  • read the directions and warnings before use
  • store at 20º to 25ºC (68º to 77ºF)
  • protect from moisture
Section 50565-1

Keep out of reach of children.

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

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 are taking 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 51727-6

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

Section 51945-4

curist

Acid Relief

Famotidine Tablets, 10mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Dut to Acid Indigestion

300 Tablets

Section 53413-1

Questions or comments?

Call 1-844-243-1241 or email [email protected]

Section 53414-9

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

Section 55105-1

Acid reducer

Section 55106-9

Active Ingredient (in each tablet)

Famotidine USP 10mg


Structured Label Content

Indications and Usage (34067-9)
  • relieves heartburn associated with acid indigestion and sour stomach
  • prevents heartburn associated with acid indigestion and sour stomach brough on by eating or drinking certain food and beverages
Dosage and Administration (34068-7)

Directions

  • adults and children 12 years and over:
  • to relieve symtoms, 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 15 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

Warnings and Precautions (34071-1)

Alergy Alert

Do not us if allergic to Famotidine or other acid reducers

Section 42229-5 (42229-5)

Tips for Managing Heartburn

  • Do not lie flat or bend over after eating
  • Do not wear tight fitting clothing around th estomach
  • Do not eat before bedtime
  • Raise the head of your bed
  • Avoid heartburn-causing foods such as rich, spicy, fatty or fried foods, chocolate, caffeine, alcohol, and certain fruits and vegetables

Just One Tablet prevents and relieves heartburn die to acid indigestion brough on by leating and drinking certain foods and beverages

Important: Read all directions and warnings before use. Tamper Evident: Do not use if imprented inner safety seal is torn or missing

Drug Facts

Section 44425-7 (44425-7)

Other Information

  • read the directions and warnings before use
  • store at 20º to 25ºC (68º to 77ºF)
  • protect from moisture
Section 50565-1 (50565-1)

Keep out of reach of children.

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

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 are taking 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 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

curist

Acid Relief

Famotidine Tablets, 10mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Dut to Acid Indigestion

300 Tablets

Section 53413-1 (53413-1)

Questions or comments?

Call 1-844-243-1241 or email [email protected]

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Acid reducer

Section 55106-9 (55106-9)

Active Ingredient (in each tablet)

Famotidine USP 10mg


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)