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NDC 71205-0314-04 MEDI-FIRST Non-Aspirin Extra Strength 500 mg/1 Details
MEDI-FIRST Non-Aspirin Extra Strength 500 mg/1
MEDI-FIRST Non-Aspirin Extra Strength is a ORAL TABLET, FILM COATED in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. 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: 71205-0314-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 71205-0314 |
|---|---|
| Product ID | 71205-314_06b51a94-6ec9-4d8a-b9fc-70547c5ffa88 |
| 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 | MEDI-FIRST Non-Aspirin Extra Strength |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 500 |
| Active Ingredient Units | mg/1 |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 71205-0314-04 (71205031404)
| NDC Package Code | 71205-314-04 |
|---|---|
| Billing NDC | 71205031404 |
| Package | 4 TABLET, FILM COATED in 1 PACKET (71205-314-04) |
| Marketing Start Date | 2019-09-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9071b047-5463-4f65-b775-bfb0ce066527 Details
Uses
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- •
- more than 8 tablets in 24 hours, which is the maximum daily amount
- •
- 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. - •
- for more than 10 days for pain unless directed by a doctor
- •
- for more than 3 days for fever unless directed by a doctor
Directions
Other information
Inactive ingredients
Medi-First Plus XS Non-Aspirin Label
8 Tablets
Extra Strength
Non-Aspirin
Acetaminophen/Acetaminofeno 500mg
Pull To Open
Tire Para Abrir
Pain Reliever/Fever Reducer
Alivia el Dolar/Reduce La Fiebre
Compare Active ingredient to:
Extra Strength Tylenol®
Registered Trademark of McNeil Consumer
Tamper Evident Unit Dose Packets
Empaquetado con sellado
Evidente en dosis unitarias
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
INGREDIENTS AND APPEARANCE
| MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH
acetaminophen tablet, film coated |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(71205-314) , RELABEL(71205-314) | |