FDA Label for Basic Care Famotidine
View Indications, Usage & Precautions
- ACTIVE INGREDIENT (IN EACH TABLET)
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- REPACKAGING INFORMATION
- PRINCIPAL DISPLAY PANEL - 20 MG
Basic Care Famotidine Product Label
The following document was submitted to the FDA by the labeler of this product Aphena Pharma Solutions - Tennessee, Llc. 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.
Active Ingredient (In Each Tablet)
Famotidine 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
• 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.• if you have kidney disease, except under the advice and supervision of a doctor• with other acid reducers
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
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.
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 minutesbefore 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• keep the carton. It contains important information.• store at 20°-25°C (68°-77°F)• protect from moisture and light
Inactive Ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide
Repackaging Information
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
| Count | 20 mg |
| 90 | 71610-389-60 |
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Repackaged by:
Cookeville, TN 38506
20200219JH
Principal Display Panel - 20 Mg
NDC 71610-389 - Famotidine, USP 20 mg Tablets
* Please review the disclaimer below.