SPL UNCLASSIFIED

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)

OTC - PURPOSE SECTION

Acid reducer

INDICATIONS AND USAGE

• relieves heartburn associated with acid indigestion and sour stomach
• prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages

WARNINGS

Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers

OTC - 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.

OTC - ASK DOCTOR

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

OTC - STOP USE

• 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. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

• adults and children 12 years and over:

          ○ to relieve symptoms, swallow 1 tablet with a glass of water

          ○ to prevent symptoms, swallow 1 tablet with a glass of water 30 to 60 minutes before eating food or drinking beverages that cause              heartburn

          ○ can be used up to twice daily (do not take more than 2 tablets in 24 hours)

          ○ do not chew tablet

• children under 12 years: ask a doctor

STORAGE AND HANDLING

• Blister: do not use if individual unit is open or torn Bottle: do not use of printed foil under bottle cap is open or torn
• store at 20°-25°C (68°-77°F)
• avoid excessive heat or humidity
• this product is sodium and sugar free

INACTIVE INGREDIENT

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearte, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide

OTC - QUESTIONS

call 1-800-406-7984

SPL UNCLASSIFIED

IMPORTANT

Read the directions, consumer information leaflet and warnings before use. It contains important information.

Distributed by: Ohm Laboratories Inc, 1385 Livingston Avenue, North Brunsluick, NJ 08902

MADE IN INDIA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL