Heb Acid Controller Drug Facts

Heb Acid Controller Drug Facts
SPL v3
SPL
SPL Set ID 8aac5a0d-074b-4cf4-ab10-549e1ed09e2f
Route
ORAL
Published
Effective Date 2025-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Famotidine (20 mg)
Inactive Ingredients
Silicon Dioxide Croscarmellose Sodium Fd&c Blue No. 1 Hypromellose, Unspecified Lactose Monohydrate Magnesium Stearate Maltodextrin Microcrystalline Cellulose Sucralose Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Imprint: 32F Shape: round Color: blue Size: 8 mm Score: 1
Marketing Status
ANDA Active Since 2022-06-06

Description

Famotidine 20 mg

Purpose

Acid reducer


Medication Information

Purpose

Acid reducer

Description

Famotidine 20 mg

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
  • 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, vomiting with blood, or bloody or black stools. These may be signs of a serious condition. See your doctor.
  • with 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˚-77˚F)
  • protect from moisture
Inactive Ingredients

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose (monohydrate), magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, natural and artificial flavor, sucralose, titanium dioxide, triacetin

Questions Or Comments?

1-800-719-9260

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

Active Ingredient (in Each Tablet)

Famotidine 20 mg

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
Package/label Principal Display Panel

Compare to Maximum Strength Pepcid® AC active ingredient

H-E-B®

Maximum Strength

Acid Controller

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Cool Mint Flavor

Releases a cooling sensation in mouth & throat

actual size

25 TABLETS

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
  • prevents 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 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
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)

colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1 aluminum lake, hypromellose, lactose (monohydrate), magnesium stearate, maltodextrin, microcrystalline cellulose, modified food starch, natural and artificial flavor, sucralose, titanium dioxide, triacetin

Questions Or Comments? (Questions or comments?)

1-800-719-9260

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

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

Famotidine 20 mg

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 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
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Compare to Maximum Strength Pepcid® AC active ingredient

H-E-B®

Maximum Strength

Acid Controller

Famotidine Tablets, 20 mg

Acid Reducer

Just One Tablet Prevents & Relieves Heartburn Due to Acid Indigestion

Cool Mint Flavor

Releases a cooling sensation in mouth & throat

actual size

25 TABLETS

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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