OTC Medication Information: Famotidine – Acid Controller

FAMOTIDINE — ACID CONTROLLER- famotidine tablet, film coated
WinCo Foods, LLC

Drug Facts

Active ingredient (in each tablet)

Famotidine, USP 10 mg
Famotidine, USP 20 mg

Purpose

Acid reducer

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

Do not use

Famotidine USP, 10 mg

  • with other acid reducers
  • 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.

Famotidine USP, 20 mg

  • with other acid reducers
  • if you have kidney disease, except under the advice and supervision of a doctor.
  • 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.

Ask a doctor before use if you have

  • frequent chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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

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).

Directions

Famotidine USP, 10 mg

  • 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 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

Famotidine USP, 20 mg

  • 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

Other information

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

Inactive ingredients

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, iron oxide red (only for Famotidine USP, 10 mg), magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

Questions?

or to report an adverse event call 800-824-1706 Monday — Friday 9am — 4pm MST

DISTRIBUTED BY: WINCO FOODS, LLC, BOISE, ID 83704

PRINCIPAL DISPLAY PANEL — 10 mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC® Original Strength

WinCo™
FOODS
ORIGINAL STRENGTH
Acid Controller

FAMOTIDINE TABLETS,
USP 10 mg/
ACID REDUCER
JUST ONE TABLET Prevents & Relieves Heartburn
Due to Acid Indigestion

30 Tablets

PRINCIPAL DISPLAY PANEL -- 10 mg Blister Pack Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 20 mg Blister Pack Carton

*Compare to the active ingredient in PEPCID AC® Maximum Strength

WinCo™
FOODS
MAXIMUM STRENGTH
Acid Controller

FAMOTIDINE TABLETS,
USP 20 mg/
ACID REDUCER
JUST ONE TABLET Prevents & Relieves Heartburn
Due to Acid Indigestion

25 Tablets

PRINCIPAL DISPLAY PANEL -- 20 mg Blister Pack Carton
(click image for full-size original)
FAMOTIDINE — ACID CONTROLLER famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-242
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 10 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1200000 MW)
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE RED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 035
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-242-30 30 TABLET, FILM COATED in 1 BLISTER PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 05/01/2012
FAMOTIDINE — ACID CONTROLLER famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-241
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FAMOTIDINE (FAMOTIDINE) FAMOTIDINE 20 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
HYDROXYPROPYL CELLULOSE (1200000 MW)
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 400
STARCH, CORN
TALC
TITANIUM DIOXIDE
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 036
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67091-241-25 25 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090283 05/01/2012
Labeler — WinCo Foods, LLC (056098817)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (67091-241), MANUFACTURE (67091-242)

Revised: 09/2018 WinCo Foods, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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