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NDC 55111-0404-34 Ranitidine 150 mg/1 Details
Ranitidine 150 mg/1
Ranitidine is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Dr. Reddy's Laboratories Limited. The primary component is RANITIDINE HYDROCHLORIDE.
Product Information
| NDC | 55111-0404 |
|---|---|
| Product ID | 55111-404_8459fe61-6721-7cfb-31a4-b05105bc73b8 |
| Associated GPIs | 49200020100305 |
| GCN Sequence Number | 011673 |
| GCN Sequence Number Description | ranitidine HCl TABLET 150 MG ORAL |
| HIC3 | Z2D |
| HIC3 Description | HISTAMINE H2-RECEPTOR INHIBITORS |
| GCN | 10200 |
| HICL Sequence Number | 004520 |
| HICL Sequence Number Description | RANITIDINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | Ranitidine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ranitidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 150 |
| Active Ingredient Units | mg/1 |
| Substance Name | RANITIDINE HYDROCHLORIDE |
| Labeler Name | Dr. Reddy's Laboratories Limited |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA078192 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 55111-0404-34 (55111040434)
| NDC Package Code | 55111-404-34 |
|---|---|
| Billing NDC | 55111040434 |
| Package | 1 BOTTLE in 1 CARTON (55111-404-34) / 24 TABLET, COATED in 1 BOTTLE |
| Marketing Start Date | 2009-12-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 00df8a42-296f-80dd-98af-ee8b30eb38cc Details
Use(s)
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
- 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
- kidney disease
Ask a doctor or pharmacist before use if you are
• taking a prescription drug. Acid reducers may interact with certain prescription drugs.
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
Inactive ingredients
Questions?
SPL UNCLASSIFIED SECTION
Tips for managing heartburn
- Do not lie flat or bend over soon after eating
-
Do not eat late at night, or just before bedtime
-
Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, and even some fruits and vegetables.
-
Eat slowly and do not eat beig meals
-
If you are overweight, lose weight
-
If you smoke, quit smoking
-
Raise the head of your bed
-
Wear loose fitting clothing around your stomach.
Revised: 03/20
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| RANITIDINE
ranitidine tablet, coated |
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| Labeler - Dr. Reddy's Laboratories Limited (650562841) |
Revised: 4/2020
Document Id: 8459fe61-6721-7cfb-31a4-b05105bc73b8
Set id: 00df8a42-296f-80dd-98af-ee8b30eb38cc
Version: 11
Effective Time: 20200420