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NDC 63187-0999-60 heartburn relief 10 mg/1 Details
heartburn relief 10 mg/1
heartburn relief is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is FAMOTIDINE.
MedlinePlus Drug Summary
Prescription famotidine is used to treat ulcers (sores on the lining of the stomach or small intestine); gastroesophageal reflux disease (GERD, a condition in which backward flow of acid from the stomach causes heartburn and injury of the esophagus [tube that connects the mouth and stomach]); and conditions where the stomach produces too much acid, such as Zollinger-Ellison syndrome (tumors in the pancreas or small intestine that cause increased production of stomach acid). Over-the-counter famotidine is used to prevent and treat heartburn due to acid indigestion and sour stomach caused by eating or drinking certain foods or drinks. Famotidine is in a class of medications called H2 blockers. It works by decreasing the amount of acid made in the stomach.
Related Packages: 63187-0999-60Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine
Product Information
| NDC | 63187-0999 |
|---|---|
| Product ID | 63187-999_6df77a1c-accd-4559-9a9a-00a030f6ba64 |
| Associated GPIs | 49200030000310 |
| GCN Sequence Number | 021688 |
| GCN Sequence Number Description | famotidine TABLET 10 MG ORAL |
| HIC3 | Z2D |
| HIC3 Description | HISTAMINE H2-RECEPTOR INHIBITORS |
| GCN | 46432 |
| HICL Sequence Number | 004521 |
| HICL Sequence Number Description | FAMOTIDINE |
| Brand/Generic | Generic |
| Proprietary Name | heartburn relief |
| Proprietary Name Suffix | original strength |
| Non-Proprietary Name | Famotidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/1 |
| Substance Name | FAMOTIDINE |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA075400 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0999-60 (63187099960)
| NDC Package Code | 63187-999-60 |
|---|---|
| Billing NDC | 63187099960 |
| Package | 60 TABLET in 1 BOTTLE (63187-999-60) |
| Marketing Start Date | 2018-04-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 5567aaaf-b4f2-4604-b841-c9447e77256c Details
Uses
Warnings
Allergy alert: Do not use if you are allergic to famotidine 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
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- had heartburn over 3 months. This may be a sign of a more serious condition.
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- 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
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- frequent chest pain
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- frequent wheezing, particularly with heartburn
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- unexplained weight loss
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- nausea or vomiting
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- stomach pain
Directions
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- adults and children 12 years and over:
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- to relieve symptoms, swallow 1 tablet with a glass of water. Do not chew.
- •
- to prevent symptoms, swallow 1 tablet with a glass of water 60 minutes before eating food or drinking beverages that cause heartburn
- •
- do not use more than 2 tablets in 24 hours
- •
- children under 12 years: ask a doctor
Other information
Inactive ingredients
Principal Display Panel
INGREDIENTS AND APPEARANCE
| HEARTBURN RELIEF
ORIGINAL STRENGTH
famotidine tablet |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-999) , RELABEL(63187-999) | |
Revised: 10/2019
Document Id: 6df77a1c-accd-4559-9a9a-00a030f6ba64
Set id: 5567aaaf-b4f2-4604-b841-c9447e77256c
Version: 3
Effective Time: 20191001