Famotidine – Acid Controller: Package Insert and Label Information

FAMOTIDINE — ACID CONTROLLER- famotidine tablet, film coated
Ohm Laboratories Inc.

ACTIVE INGREDIENT (IN EACH TABLET)

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

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

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.
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR INDIVIDUAL BLISTER UNIT IS OPEN OR TORN. (for blister carton)
TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for bottle carton/label)
TAMPER EVIDENT: DO NOT USE IF THE PRINTED FOIL UNDER CAP IS OPEN OR TORN. (for SAL/extended label)

INACTIVE INGREDIENTS

colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, pregelatinized starch, talc, titanium dioxide

QUESTIONS?

call 1-800-406-7984

PATIENT INFORMATION

JUST ONE TABLET prevents and relieves heartburn due to acid indigestion brought on by eating and drinking certain foods and beverages.

See end panel for batch number and expiration date. (for carton only)

Tips for Managing Heartburn

Do not lie flat or bend over after eating
Do not wear tight-fitting clothing around the stomach
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
Eat slowly and avoid big meals
If overweight, lose weight
Quit smoking

Principal Display Panel

Compare to the active ingredient of Maximum Strength Pepcid AC ® .

NDC 51660-036-26

ohm ®

MAXIMUM STRENGTH

Acid Controller

Famotidine Tablets, USP 20 mg

Acid Reducer

Just One Tablet

Prevents & Relieves Heartburn

Due to Acid Indigestion

25 TABLETS

Distributed by: Ohm Laboratories Inc.

5142565/R0517

20 mg 25 ct
(click image for full-size original)

25’s Blister Carton

FAMOTIDINE — ACID CONTROLLER
famotidine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51660-036
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 (TYPE H)
HYPROMELLOSES
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
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:51660-036-26 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 05/31/2017
Labeler — Ohm Laboratories Inc. (184769029)
Registrant — Ranbaxy Pharmaceuticals Inc. (937890044)
Establishment
Name Address ID/FEI Operations
Ohm Laboratories Inc. 184769029 MANUFACTURE (51660-036)

Revised: 11/2017 Ohm Laboratories Inc.

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