Medicine guide

Pain Relief

500 mg · Tablet, Coated

  • Available without prescription
Active substance
Acetaminophen
Made by
Demoulas Super Markets, Inc

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-07-16

What it is

Pain reliever/fever reducer

Used for
  • The common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps temporarily reduces fever
How to take it

Adults and children 12 years and over: take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve

do not take more than 6 tablets in 24 hours, unless directed by a doctor

Full directions ↓
Do not take it if

With any other drug containing acetaminophen (prescription or nonprescription).

All warnings ↓
Good to know
  • Sold without a prescription
  • FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
828other products contain Acetaminophen — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

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

From the official label · 2025-07-16 · DailyMed

How it works

From the US prescribing label for the same active substance (Acetaminophen). It describes the substance, not this exact product.

The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions.

Peak level after15 min
How the body breaks it down

With therapeutic doses, NAPQI undergoes rapid conjugation with glutathione and is then further metabolized to form cysteine and mercapturic acid conjugates.

How it leaves the body

Acetaminophen metabolites are mainly excreted in the urine.

Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2026-08-28

Do not take it if

  • 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

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

  • do not take more than directed (see overdose warning )
  • adults and children 12 years and over
  • take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve
  • do not take more than 6 tablets 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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first if

liver disease.

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first if

you are taking the blood thinning drug warfarin

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help 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.

Quoted from the official label, section “OTC — Stop Use”.

Other 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).
  • 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.
  • Keep out of reach of children.
  • 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.

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

How to store it

store between 20-25°C (68-77°F) retain carton for complete product information

Quoted from the official label, section “Storage and Handling”.

What kind of medicine it is

Pain reliever/fever reducer

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

acesulfame potassium, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-844-705-4384

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

  • Colour dyesFD&C red #40 aluminum lake; FD&C yellow #6 aluminum lakeSome people react to dyes such as tartrazine (Yellow 5) or carmine.
  • Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (286)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Hide versions whose label lists:

Showing 80 of 80 (the first 80 are listed)

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Made byDemoulas Super Markets, Inc
Active substanceAcetaminophen
Strength500 mg
FormTablet, Coated
RouteOral
Packs1 BOTTLE, PLASTIC in 1 CARTON / 100 TABLET, COATED in 1 BOTTLE, PLASTIC · 225 TABLET, COATED in 1 BOTTLE, PLASTIC
NDC53942-092
NDC53942-170

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Other strengths and forms

54 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.