Extra Strength Pain Reliever Mini Softgels Capsule, Liquid Filled
FDA Label NDC 83059-0168

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Shield Pharmaceuticals Corp for the product Extra Strength Pain Reliever Mini Softgels (NDC 83059-0168). 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 drug fact, active ingredients (in each softgel), purpose, uses, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Fact

Active Ingredients (In Each Softgel)

Acetaminophen 500 mg

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 4,000 mg of acetaminophen 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.

Otc - Do Not Use

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

Otc - Ask Doctor

Ask a doctor before use if you have

  • liver disease

Otc - Ask Doctor/Pharmacist

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin

Otc - Stop Use

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.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Overdosage

Overdose warning
In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

  • do not use more than directed(see overdose warning)
    • adults and children 12 years and over:
    • take 2 softgels every 6 hours while symptoms last
    • do not take more than 6 softgels 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

Other Information

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients

FD&C Red No. 40, gelatin, glycerin, isopropyl alcohol, N-butyl alcohol, polyethylene glycol, polysorbate 80, propylene glycol, purified water, shellac, sorbitol solution, titanium dioxide

Questions Or Comments?

1-800-373-6981

Other

Distributed by:
Shield Pharmaceuticals Corp.
Ronkonkoma, NY 11779

Principal Display

Extra Strength
Pain Reliever
mini softgels

Acetaminophen 500 mg
Pain reliever / Fever reducer

Carton

Label

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