FDA Label for Famotidine
View Indications, Usage & Precautions
- DRUG FACTS
- OTC - PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- OTC - ASK DOCTOR
- OTC - ASK DOCTOR/PHARMACIST
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- OTHER
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Famotidine Product Label
The following document was submitted to the FDA by the labeler of this product Leader/ Cardinal Health 110, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
Active ingredient(in each tablet)
Famotidine 20 mg
Otc - Purpose
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.
Otc - 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
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.
Otc - Stop Use
Stop use and ask a doctor if
- side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
- your heartburn continues or worsens
- you need to take this product for more than 14 days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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 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
Other Information
- read the directions and warnings before use
- store at 20°-25°C (68°-77°F)
- protect from moisture
- meets USP Dissolution Test 2
Inactive Ingredient
colloidal silicon dioxide, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch, sodium starch glycolate, talc, titanium dioxide.
Otc - Questions
Questions or comments?
1-800-231-4670:
weekdays 9am-5pm EST
Other
DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
*This product is not manufactured or distributed by Kenvue Inc., owner of the registered trademark Pepcid AC®.
KEEP OUTER PACKAGE FOR COMPLETE PRODUCT INFORMATION
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Package Label.Principal Display Panel
NDC 70000-0710-1
Maximum Strength
Acid Reducer
Famotidine Tablets USP, 20 mg
Just One Tablet Prevents
& Relieves Heartburn Due
to Acid Indigestion
COMPARE TO MAXIMUM STRENGTH PEPCID AC® active ingredient*
200
TABLETS
* Please review the disclaimer below.
