Ranitidine Tablet USP, 150 mg
OTC - ACTIVE INGREDIENT SECTION
Ranitidine 150 mg (as ranitidine hydrochloride 168 mg)
OTC - PURPOSE SECTION
Acid reducer
USE
- 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 foods and beverages
WARNINGS
Allergy alert: Do not use if you are allergic to ranitidine 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.
● with other acid reducers
● if you have kidney disease, except under the advice and supervision of a doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
o frequent chest pain
o frequent wheezing, particularly with heartburn
o unexplained weight loss
o nausea or vomiting
o stomach pain
o had heartburn over 3 months. This may be a sign of a more serious condition.
o heartburn with lightheadedness, sweating or dizziness
o 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
o your heartburn continues or worsens
o 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
▪ 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)
● children under 12 years: ask a doctor
OTHER INFORMATION
- Blister: Do not use if individual unit is open or torn
- Bottle: do not use if 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 sugar free
INACTIVE INGREDIENT
colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, FD&C Yellow No. 6, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.
SPL UNCLASSIFIED SECTION
Read the directions, consumer information leaflet and warnings before use. Keep the carton. It contains important information.
Manufactured by:
Wockhardt Limited,
Mumbai, India.
Distributed by:
Wockhardt USA LLC.
20 Waterview Blvd.
Parsippany, NJ 07054
USA.
Iss.020410