Maximum Strength

Maximum Strength
SPL v5
SPL
SPL Set ID f18c1195-48a1-69dc-e053-2a95a90a4077
Route
ORAL
Published
Effective Date 2023-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Titanium Dioxide Microcrystalline Cellulose Sodium Starch Glycolate Type A Magnesium Stearate Talc Hydroxypropyl Cellulose (110000 Wamw) Triacetin Starch, Corn Hypromellose 2910 (6 Mpa.s) Polyethylene Glycol 4000

Identifiers & Packaging

Pill Appearance
Imprint: V;15 Shape: round Color: white Size: 6 mm Score: 1
Marketing Status
ANDA Active Since 2023-06-30

Description

Famotidine Tablets USP, 20mg

Purpose

Acid Reducer


Medication Information

Purpose

Acid Reducer

Description

Famotidine Tablets USP, 20mg

Pdp

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
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
  • if you have trouble or pain swallowing food, vomitiing with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers
Allergy Alert

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

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

hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium

starch glycolate, talc, titanium dioxide, triacetin

Questions Or Comments?

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

Stop Use and Ask A Doctor If
  • your heartburn continues or worsens
  • you need to take this product for more than 14 days
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)

If Pregnant Or Breast Feeding,

ask a health professional before use

Active Ingredient (in Each Tablet)

Famotidine Tablets 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 lighteasdedness, 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 Before Use If You Are

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


Structured Label Content

Pdp (PDP)

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
Purpose

Acid Reducer

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, vomitiing with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with other acid reducers
Allergy Alert (Allergy alert)

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

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

hydroxypropyl cellulose, hypromellose, macrogol, magnesium stearate, microcrystalline cellulose, pre-gelatinized starch, sodium

starch glycolate, talc, titanium dioxide, triacetin

Questions Or Comments? (Questions or Comments?)

call 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST

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

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

ask a health professional before use

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

Famotidine Tablets 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 lighteasdedness, 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 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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