Label: MEDI-FIRST NON-ASPIRIN EXTRA STRENGTH- acetaminophen tablet, film coated
- NDC Code(s): 71205-314-04, 71205-314-08
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 47682-804
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated February 5, 2020
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- 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
- QUESTIONS
-
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 coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71205-314(NDC:47682-804) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code AZ;235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71205-314-04 4 in 1 PACKET; Type 0: Not a Combination Product 09/01/2019 2 NDC:71205-314-08 8 in 1 PACKET; Type 0: Not a Combination Product 02/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(71205-314) , RELABEL(71205-314)