Ranitidine Hydrochloride: Package Insert and Label Information

RANITIDINE HYDROCHLORIDE- ranitidine hydrochloride tablet, film coated
Select Brand

ACTIVE INGREDIENT (IN EACH TABLET)

Ranitidine 75 mg (as ranitidine hydrochloride USP, 84 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 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 chest pain
  • frequent wheezing, particularly with heartburn
  • unexplained weight loss
  • nausea or vomiting
  • stomach pain
  • 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 (1-800-222-1222).

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

  • TAMPER EVIDENT: DO NOT USE IF THE CARTON OR PRINTED FOIL UNDER 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 INGREDIENTS

Colloidal silicon dioxide, croscarmellose sodium, hypromellose, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, talc, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL

NDC 15127-711-30

select brand ®

Regular Strength

Ranitidine Tablets, USP 75 mg

Acid Reducer

Prevents & Relieves Heartburn Associated with Acid Indigestion & Sour Stomach

Compare to the active ingredient of Zantac 75 ®

30 Tablets

Distributed by: SELECT BRAND® DISTRIBUTORS

5094996/0412

This is the 30 count bottle carton label for Select Brand Ranitidine tablets, USP 75 mg.
(click image for full-size original)
RANITIDINE HYDROCHLORIDE
ranitidine hydrochloride tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:15127-711
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
RANITIDINE HYDROCHLORIDE (RANITIDINE) RANITIDINE 75 mg
Inactive Ingredients
Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSCARMELLOSE SODIUM
HYPROMELLOSES
FERRIC OXIDE RED
MAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL 400
TALC
TITANIUM DIOXIDE
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code OR;606
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:15127-711-30 30 TABLET, FILM COATED (TABLET) in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA201745 07/10/2012
Labeler — Select Brand (043562370)
Registrant — Ohm Laboratories Inc. (184769029)
Establishment
Name Address ID/FEI Operations
Shasun Pharmaceuticals Limited 915786829 manufacture (15127-711)

Revised: 09/2012 Select Brand

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2021. All Rights Reserved.