Label: HENRY SCHEIN ACETAMINOPHEN- acetaminophen tablet, film coated
- NDC Code(s): 0404-0716-13, 0404-0716-99
- Packager: Henry Schein, Inc.
- 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.
Drug Label Information
Updated March 15, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg 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.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
-
DOSAGE & ADMINISTRATION
Directions
- do not use more than directed (see overdose warning)
Adults and children: (12 years and older)
- take 2 tablets every 4 to 6 hours while symptoms last
- do not take more than 6 tablets in 24 hours unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
Children under 12 years: Ask a doctor
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
-
Henry Schein XS Acetaminophen Label
NDC #0404-0716-13
Henry Schein®
Extra Strength Acetaminophen
For the temporary relief of minor aches and pains associated with the headache, muscular aches, minor arthritis pain, common cold, toothache, menstrual cramps and for the reduction of fever.
Henry Schein Seal of Excellence®
This Package is for Households without Young Children.
Acetaminophen 500 mg
250 Packets/2 Tablets
Reorder
900-4690
-
INGREDIENTS AND APPEARANCE
HENRY SCHEIN ACETAMINOPHEN
acetaminophen tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0716 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 SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSES (UNII: 3NXW29V3WO) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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:0404-0716-13 250 in 1 BOX 12/30/2008 1 NDC:0404-0716-99 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 - Henry Schein, Inc. (012430880) Registrant - Unifirst First Aid Corporation (832947092)