Handy Solutions Acetaminophen
FDA Label NDC 67751-161

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navajo Manufacturing Company Inc. for the product Handy Solutions Acetaminophen (NDC 67751-161). 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 caplet), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, stop use 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 Caplet)

Acetaminophen 500 mg

Purpose

Pain Reliever/Fever Reducer

Uses

For the temporary relief of minor aches and pains associated with:

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

For the reduction of fever.

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

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 Use And Ask A Doctor If

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

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

In case of 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.

Directions

Adults and children 12 years of age 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 of age: 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

  • Tamper evident. Do not ues if packet is torn, cut or opened
  • Store at controlled room temperatures 15° to 30° C (59 to 86°F)

Inactive Ingredients

corn starch, hypromellose, maltodextrin*, microcrystalline cellulose*, polyethylene glycol, povidone*, pregelatinized starch*, sodium starch glycolate*, stearic acid, titanium dioxide*

*may contain

Questions Or Comments?

call 1-800-525-5097

* Please review the disclaimer below.