Label: FIRST AID ONLY EXTRA-STRENGTH NON-ASPIRIN- acetaminophen tablet, film coated
- NDC Code(s): 0924-0228-01
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 47682-125
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated March 30, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
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
Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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
Stop using and ask a doctor if
- symptoms do not improve
- pain or fever persists or gets worse
- new symptoms occur
- redness or swelling is present
- do not use more than directed
Adults and children: (12 years and older)
Take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.
- Other information
- Inactive ingredients
- First Aid Only Extra-Strength Non-Aspirin Label
INGREDIENTS AND APPEARANCE
FIRST AID ONLY EXTRA-STRENGTH NON-ASPIRIN
acetaminophen tablet, film coated
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0228(NDC:47682-125) 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSES (UNII: 3NXW29V3WO) MALTODEXTRIN (UNII: 7CVR7L4A2D) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 12mm Flavor Imprint Code FR;33 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0228-01 20 in 1 BOX, UNIT-DOSE 12/30/2008 1 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/30/2008 Labeler - Acme United Corporation (001180207) Registrant - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-0228) , repack(0924-0228) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-0228) , repack(0924-0228)