Henry Schein Acetaminophen Tablet, Film Coated
FDA Label NDC 0404-0716

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Henry Schein, Inc. for the product Henry Schein Acetaminophen (NDC 0404-0716). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each tablet), purpose, uses, other, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if, stop using and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each Tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

For the temporary relief of minor aches and pains associated with

  • headache
  • minor arthritis pain
  • common cold
  • toothache
  • muscular aches
  • menstrual cramps

    • For the reduction of fever.

Other

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

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

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 Using And Ask A Doctor If

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Directions

  • 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.

Children Under 12 Years:

Do not give this adult strength product to children under 12 years of age;

this will provide more than the recommended dose (overdose) and may cause

liver damage.

Other Information

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive Ingredients

corn starch, hypromellose, povidone*, pregelatinized corn starch, sodium starch glycolate*, stearic acid, titanium dioxide

Otc - Questions

Questions or comments? 1-800-472-4346

Package Label.Principal Display Panel

175R 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®

Reorder

900-4690

See new warnings information

Acetaminophen 500 mg

250 Packets/2 Tablets

* Please review the disclaimer below.