OTC Medication Information: RANITIDINE

RANITIDINE — ranitidine hydrochloride tablet, coated
WOCKHARDT USA LLC.

Active ingredient (in each tablet) Purpose
Ranitidine 75 mg (as ranitidine hydrochloride 84 mg)…………………………………………..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 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

Ask a doctor before use if you have

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

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
    • 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 ingredients

colloidal silicon dioxide, croscarmellose sodium, diethyl phthalate, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose and titanium dioxide.

Questions or comments?

Call 1-800-346-6854
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

Bulk Label
(click image for full-size original)

RANITIDINE
ranitidine tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:64679-740
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE HYDROCHLORIDE 75 mg
Product Characteristics
Color pink (Pink colored film coated) Score no score
Shape HEXAGON (6 sided) Size 8mm
Flavor Imprint Code W;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64679-740-01 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
1 10 TABLET, COATED (TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-740-01)
2 NDC:64679-740-02 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
2 100 TABLET, COATED (TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-740-02)
3 NDC:64679-740-04 1 BOTTLE (BOTTLE) in 1 CARTON contains a BOTTLE
3 500 TABLET, COATED (TABLET) in 1 BOTTLE This package is contained within the CARTON (64679-740-04)
4 NDC:64679-740-03 10 BLISTER PACK (BLISTER PACK) in 1 CARTON contains a BLISTER PACK
4 10 TABLET, COATED (TABLET) in 1 BLISTER PACK This package is contained within the CARTON (64679-740-03)
5 NDC:64679-740-05 10000 TABLET, COATED (TABLET) in 1 POUCH None
6 NDC:64679-740-00 60000 TABLET, COATED (TABLET) in 1 DRUM None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078884 07/31/2008
Labeler — WOCKHARDT USA LLC. (170508365)

Revised: 04/2010 WOCKHARDT USA LLC.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.