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OTC products · Product label record

Extra Strength Pain Reliever drug information

ACETAMINOPHEN
Shield Pharmaceuticals Corp. · ORAL

Product NDC: 83059-0181

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameACETAMINOPHEN
Labeler / manufacturerShield Pharmaceuticals Corp.
RouteORAL
Drug classDrug class not supplied in source label
Product NDC83059-0181
Label effective date2026-09-02

Official product label reference

Extra Strength Pain Reliever — Shield Pharmaceuticals Corp.

This page contains 16 source sections for ACETAMINOPHEN, oral route. Label set 78052120-40d8-4a3f-b72f-cc78ca76213b, version 2.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

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

Purpose

Purpose Pain reliever/fever reducer
Dosage and administration — label text
Directions do not use more than directed (see Overdose warning) adults and children 12 years and over take 2 caplets every 6 hours do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 6 years ask a doctor Table text from source: | adults and children 12 years and over | take 2 caplets every 6 hoursdo not take more than 6 caplets in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctor | children under 6 years | ask a doctor
Warnings
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. 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.
Unclassified section
Drug Facts Active ingredient (in each caplet) Acetaminophen 500 mg Purpose Pain reliever/fever reducer Distributed by: Shield Pharmaceuticals Corp. Ronkonkoma, NY 11779
Active ingredient
Active ingredient (in each caplet) Acetaminophen 500 mg
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
Ask a doctor before use
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
When to stop use and seek help
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.
Pregnancy or breast feeding
If pregnant or breast-feeding, ask a health professional before use.
Child safety
Keep out of reach of children.
Overdose information
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.
Other safety information
Other information store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
Inactive ingredient
Inactive ingredients magnesium stearate, potassium sorbate, povidone (K30), pregelatinized starch, purified water, sodium starch glycolate
Questions
Questions or comments? 1-800-373-6981

Official sources and product identifiers

Substances listed: ACETAMINOPHEN

RxNorm identifiers: 198440

Package NDC codes

83059-0181-1

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.