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NDC 57896-0207-01 Extra Strength Acetaminophen 500 mg/1 Details
Extra Strength Acetaminophen 500 mg/1
Extra Strength Acetaminophen is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Geri-Care Pharmaceutical Corp. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 57896-0207-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 57896-0207 |
|---|---|
| Product ID | 57896-207_cece1edc-e1ce-1bcf-e053-2995a90a2b9e |
| Associated GPIs | 64200010000315 |
| GCN Sequence Number | 004490 |
| GCN Sequence Number Description | acetaminophen TABLET 500 MG ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 16965 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | Extra Strength Acetaminophen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Geri-Care Pharmaceutical Corp |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 57896-0207-01 (57896020701)
| NDC Package Code | 57896-207-01 |
|---|---|
| Billing NDC | 57896020701 |
| Package | 100 TABLET in 1 BOTTLE (57896-207-01) |
| Marketing Start Date | 2020-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL b581802c-5f9e-0678-e053-2995a90ad082 Details
Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take:
- more than 8 tablets (4,000 mg of acetaminophen) in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
Do not use
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptom occur
- redness or swelling is present
These could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use..
Directions
Other Information
INGREDIENTS AND APPEARANCE
| EXTRA STRENGTH ACETAMINOPHEN
acetaminophen tablet |
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| Labeler - Geri-Care Pharmaceutical Corp (611196254) |
| Registrant - Geri-Care Pharmaceutical Corp (611196254) |