Pharbetol Tablet, Coated
FDA Label NDC 16103-350

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharbest Pharmaceuticals, Inc. for the product Pharbetol (NDC 16103-350). 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, 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 500mg

Purpose

Pain Reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
  • the common cold
  • headache
  • backache
  • minor pain of arthritis
  • toothache
  • muscular aches
  • premenstrual and menstrual cramps
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours
  • 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

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

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

    • These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Overdose Warning:

In the case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

  • do not take more than directed (see overdose warning)

    adults and children 12 years and over

    • take 2 caplets, every 6 hours while symptoms last
    • do not take more than 6 caplets in 24 hours, unless directed by a doctor
    • do not take for more than 10 days unless directed by a doctor

    children under 12 years

    ask a doctor

Other Information

  • Tamper Evident: do not use if imprinted safety seal under cap is broken or missing
  • store between 20o-25oC (68o-77oF)

Inactive Ingredients

hypromellose, povidone, pregelatinized corn starch, sodium starch glycolate, stearic acid, talc, triacetin

Questions?

Adverse drug event call: (866) 562-2756 Mon - Fri 8 AM to 4 PM

Package Label.Principal Display Panel

PHARBEST

NDC 16103-350-11

Manufactured in the USA

Extra Strength *COMPARE TO the active ingredient in EXTRA STRENGTH TYLENOL® CAPLETS

Do not use with any other product containing acetaminophen

PHARBETOL

Acetaminophen 500 mg

Pain Reliever • Fever Reducer

1000 CAPLETS

* Please review the disclaimer below.