Famotidine Tablets USP, 20 mg

OTC - ACTIVE INGREDIENT SECTION

Famotidine USP 20 mg

OTC - PURPOSE SECTION

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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

OTC - 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 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)

●  keep the carton. It contains important information.

●  protect from moisture

INACTIVE INGREDIENT

Hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, pregelatinized starch, talc and titanium dioxide.

SPL UNCLASSIFIED SECTION

Manufactured by:

Wockhardt Limited,

Mumbai, India.

Distributed by:

Wockhardt USA LLC.

20 Waterview Blvd.

Parsippany, NJ 07054

USA.

Iss.130810