FDA.reportPublic FDA data

Acetaminophen 500 mg Tablet

Manufacturer
Preferred Pharmaceuticals, Inc.
Effective date
2020-07-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:19:09

Label at a glance#

ProductPlusPharma Extra Strength PAIN RELIEVER,FEVER REDUCER 500 mg
Active ingredientACETAMINOPHEN
Label structure9 sections

Indications and uses

• for the temporary relief of minor aches and pains due to: • headache • muscular aches • backache • minor pain of arthritis • the common cold • toothache • 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 tablets every 6 hours while symptoms last • do not take more than 6 tablets 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.

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500 mg

Purposes

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. 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

Do not use

OTC - DO NOT USE SECTION

  • with any other drug containing acetaminophen (prescription or non prescription). 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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: Taking more than the recommended dose (overdose) may cause liver damage. In the 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 tablets every 6 hours while symptoms last
  • do not take more than 6 tablets 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

SPL UNCLASSIFIED SECTION

  • Do not use if imprinted safety seal under cap is broken or missing
  • Store at room temperature
  • NDC 68788-7751-02 Bottle of 20
  • NDC 68788-7751-03 Bottle of 30
  • NDC 68788-7751-04 Bottle of 45
  • NDC 68788-7751-05 Bottle of 50
  • NDC 68788-7751-06 Bottle of 60
  • NDC 68788-7751-01 Bottle of 100

Inactive ingredients

INACTIVE INGREDIENT SECTION

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid.

Questions?

OTC - QUESTIONS SECTION

If you have any questions or comments, or to report an adverse event, please contact (800) 795-9775.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PlusPHARMA

See New Warnings Information and Directions

Extra Strength

ACETAMINOPHEN 500 mg

PAIN RELIEVER FEVER REDUCER

CONTAINS NO ASPIRIN

Compare to the Active Ingredient in Extra Strength Tylenol®

This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Extra Strength Tylenol®

Repackaged by Preferred Pharmaceuticals, Inc.

Extra Strength Acetaminophen 500mg
Extra Strength Acetaminophen 500mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7751-1EA - Each68788-7751045c8c5e-20e3-4209-b5f3-890f180a9d0812021-02-05
68788-7751-2EA - Each68788-7751b50d4f98-68b2-417c-bb3c-4130765d8de712021-02-05
68788-7751-3EA - Each68788-775157233c0c-b889-4d11-9bb0-1bd430c30f1212021-02-05
68788-7751-4EA - Each68788-7751e61be1d7-fc1d-4c75-aef6-fcfd9998d77312021-02-05
68788-7751-5EA - Each68788-775156050cd1-5fc8-4acc-b4c3-ad9432f03eeb12021-02-05
68788-7751-6EA - Each68788-7751c0d88fec-ef2d-4458-b8a6-e2aeb59d265412021-02-05
51645-706-01EA - Each51645-7069d69e3fa-cc3b-4b62-a473-63c1e4b8d08912022-10-06
51645-706-10EA - Each51645-7061ecd9f01-bdc1-4496-908c-9774c760dfd912021-11-09

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-775168788-7751-2, 68788-7751-3, 68788-7751-4, 68788-7751-5, 68788-7751-6, 68788-7751-1
51645-706

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
STARCH, CORNO8232NY3SJIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
a73ab05f-3699-4202-9fae-00db9a9917150e8ee5f6-c9eb-4536-8ebc-d558644dd9a82021-05-03WarningsExact identifier
spl set id: 0e8ee5f6-c9eb-4536-8ebc-d558644dd9a8

Reported adverse events (FAERS/openFDA)#

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