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Extra Strength Acetaminophen Liquid Capsules, 500 mg Drug Facts

Manufacturer
AMERISOURCEBERGEN DRUG CORPORATION | Apotex Inc. | Accucaps Industries Limited | Accucaps Industries Limited Strathroy
Effective date
2016-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:19:45

Label at a glance#

ProductAcetaminophen
Active ingredientAcetaminophen
Label structure10 sections

Indications and 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

Dosage and administration

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

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen, USP 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • 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

OTC - ASK DOCTOR SECTION

liver disease

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

taking the blood thinning drug warfarin.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

  • store at room temperature 20°C to 25°C (68°F to 77°F)
  • do not use if printed foil under cap is broken or missing 

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, and white ink

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-800-706-5575

*This product is not manufactured or distributed by McNeil Healthcare LLC, Inc., owner of the registered trademark TYLENOL® Extra Strength.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTC Medicine

Acetaminophen, USP 500 mg

Pain reliever/fever reducer

80 liquid capsules/500 mg each

NDC 46122-388-41

Carton-Acet-500mg-80s.jpgCarton-Acet-500mg-80s.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
46122-388-41EA - Each46122-388c2919ead-974d-4ad3-a283-199aa97723c712018-03-08

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46122-38846122-388-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
Acetaminophen362O9ITL9DACTIB
Fd&C Red No. 40WZB9127XOAIACT
Gelatin2G86QN327LIACT
GlycerinPDC6A3C0OXIACT
Polyethylene Glycol 400B697894SGQIACT
Povidone K12333AG72FWJIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
Water059QF0KO0RIACT
1,4-SorbitanAV0YTZ4E6JIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
75b96d22-ef5f-742f-826c-940861d48580746fefe3-04c6-9ba3-2d17-7ef2399815bb2020-03-06WarningsExact identifier
spl set id: 746fefe3-04c6-9ba3-2d17-7ef2399815bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.