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NDC 00904-6715-46 ranitidine 75 75 mg/1 Details
ranitidine 75 75 mg/1
ranitidine 75 is a ORAL TABLET, COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Major Pharmaceuticals. The primary component is RANITIDINE HYDROCHLORIDE.
Product Information
| NDC | 00904-6715 |
|---|---|
| Product ID | 0904-6715_0b8b6ed2-7d1d-4d6d-86f9-0f86fb06b738 |
| Associated GPIs | 49200020100303 |
| GCN Sequence Number | 023441 |
| GCN Sequence Number Description | ranitidine HCl TABLET 75 MG ORAL |
| HIC3 | Z2D |
| HIC3 Description | HISTAMINE H2-RECEPTOR INHIBITORS |
| GCN | 10202 |
| HICL Sequence Number | 004520 |
| HICL Sequence Number Description | RANITIDINE HCL |
| Brand/Generic | Generic |
| Proprietary Name | ranitidine 75 |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Ranitidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, COATED |
| Route | ORAL |
| Active Ingredient Strength | 75 |
| Active Ingredient Units | mg/1 |
| Substance Name | RANITIDINE HYDROCHLORIDE |
| Labeler Name | Major Pharmaceuticals |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076195 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 00904-6715-46 (00904671546)
| NDC Package Code | 0904-6715-46 |
|---|---|
| Billing NDC | 00904671546 |
| Package | 1 BOTTLE in 1 CARTON (0904-6715-46) / 30 TABLET, COATED in 1 BOTTLE |
| Marketing Start Date | 2018-09-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL ee8565df-ff66-4986-802a-9550812026b7 Details
Uses
Do not use
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
Stop use and ask a doctor if
Keep out of reach of children.
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)
- •
- do not chew tablet
- •
- children under 12 years: ask a doctor
Other information
Inactive ingredients
Consumer information
What you should know about Regular Strength Ranitidine Tablets, 75 mg Acid Reducer
(Please read all of this information before taking Ranitidine Tablets, 75 mg. Save this leaflet for future reference.)
What are Ranitidine Tablets, 75 mg?
- •
- Ranitidine Tablets, 75 mg contain 75 mg of ranitidine (as ranitidine hydrochloride, 84 mg), a medicine that doctors have prescribed more than 200 million times worldwide.
Excellent Safety Record
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- Ranitidine Tablets, 75 mg have been used safely and effectively for years as an over-the-counter medication.
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- Ranitidine Tablets, 75 mg are sodium and sugar free.
What symptoms do Ranitidine Tablets, 75 mg relieve and prevent?
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- Ranitidine Tablets, 75 mg relieve and prevent heartburn associated with acid indigestion and sour stomach.
Certain foods or beverages, and even lying down to sleep, can cause heartburn associated with acid indigestion or sour stomach. It is normal for the stomach to produce acid, especially after consuming food or beverages. However, acid in the wrong place, such as the esophagus, or too much acid, can cause burning pain and discomfort.
How should I take Ranitidine Tablets, 75 mg?
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- 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.
This medicine can be used up to twice daily (do not take more than 2 tablets in 24 hours).
- •
- Do not chew tablet
Ranitidine Tablets, 75 mg should not be given to children under 12 years old unless directed by a doctor.
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- Allergy alert: Do not use if you are allergic to ranitidine or other acid reducers
How do Ranitidine Tablets, 75 mg work?
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- Ranitidine Tablets, 75 mg reduce the production of stomach acid. This is what makes Ranitidine Tablets, 75 mg different from antacids, which neutralize the acid already in your stomach. Antacids do not reduce the production of acid.
Additional tips for managing heartburn
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- Do not lie flat or bend over soon after eating
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- Do not eat late at night, or just before bedtime
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- Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty, and fried foods, chocolate, caffeine, alcohol, even some fruits and vegetables
- •
- Eat slowly and do not eat big meals
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- If you are overweight, lose weight
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- If you smoke, quit smoking
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- Raise the head of your bed
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- Wear loose fitting clothing around your stomach
Clinical studies prove Ranitidine Tablets, 75 mg are effective in relieving and preventing heartburn.
In clinical studies, Ranitidine Tablets, 75 mg were significantly better than placebo pills.
Percent of Heartburn Episodes Relieved
Percent of Patients with Prevention or Reduction of Heartburn Symptoms
When should I see a doctor?
- •
- 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
- •
- 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 healthcare 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)
Questions {or comments}?
BOTTLES: Bottle is sealed with printed foil under cap. Do not use if printed foil is open or torn.
BLISTERS: Do not use if the individual blister unit is open or torn.
Distributed By Perrigo ® Allegan, MI 49010
: 87600 00 J1
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| RANITIDINE 75
ranitidine tablet, coated |
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| Labeler - Major Pharmaceuticals (191427277) |