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NDC 59640-0001-63 Acid Controller 20 mg/1 Details
Acid Controller 20 mg/1
Acid Controller is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by H E B. 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: 59640-0001-63Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Famotidine
Product Information
| NDC | 59640-0001 |
|---|---|
| Product ID | 59640-001_6e81be4c-6597-46e1-87e6-a52539f9694f |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Acid Controller |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | famotidine |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 20 |
| Active Ingredient Units | mg/1 |
| Substance Name | FAMOTIDINE |
| Labeler Name | H E B |
| Pharmaceutical Class | Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077351 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 59640-0001-63 (59640000163)
| NDC Package Code | 59640-001-63 |
|---|---|
| Billing NDC | 59640000163 |
| Package | 1 BOTTLE in 1 CARTON (59640-001-63) / 25 TABLET, FILM COATED in 1 BOTTLE |
| Marketing Start Date | 2022-06-06 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 8aac5a0d-074b-4cf4-ab10-549e1ed09e2f 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
- •
- 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
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- 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. Do not chew.
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- to prevent symptoms, swallow 1 tablet with a glass of water at any time from 10 to 60 minutes before eating food or drinking beverages that cause heartburn
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- do not use more than 2 tablets in 24 hours
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- children under 12 years: ask a doctor
Other information
Inactive ingredients
Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
| ACID CONTROLLER
famotidine tablet, film coated |
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| Labeler - H E B (007924756) |