FDA.reportPublic FDA data

Acetaminophen Tablets 500 mg

Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-16 05:10:27

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure15 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 caplets every 6 hours while symptoms last • 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 12 years • ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (IN EACH CAPLET)

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 24 hours.


• with other drugs containing acetaminophen

• 3 or more alcoholic drinks everyday 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 drugs 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 other 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 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Over dose warning: In case of overdose, get medical help or Contact 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 caplets every 6 hours while symptoms last

• 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

12 years

• ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

• store at 20-25°C (68-77°F). See USP Controlled Room Temparature

• avoid high humidity


• See bottle label for lot number and expiration date

Repackaged By: Preferred Pharmaceuticals Inc.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

hydroxyethyl methyl cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

QUESTIONS OR COMMENTS ?

OTC - QUESTIONS SECTION

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

+All trademarkes are property of their reapective owners.

This product is not affliated with the makers/owners of

Extra Strength Tylenol ® Caplets.

Distributed by:

Granules Pharmaceuticals INc.,

Chantilly, VA 20151

MADE IN INDIA

Rev.08/21

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength Acetaminophen 500mg
Extra Strength Acetaminophen 500mg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128544983DEBDF-4A61-4DDE-BA34-567FDD17720E-00.jpg
Data codeData Matrix**060526*983DEBDF-4A61-4DDE-BA34-567FDD17720E-00.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-161-01EA - Each70010-1610ed1eb5c-3333-4e86-b023-551784d2efd312023-08-08
70010-161-05EA - Each70010-1612e1e4e0f-4cc6-437a-aa64-bf9985bbf91112023-08-08
70010-161-10EA - Each70010-16170fddc44-fb63-4964-a389-6514804206a812024-02-14

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68788-413268788-4132-2, 68788-4132-3, 68788-4132-5, 68788-4132-1
70010-161

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POVIDONE K30U725QWY32XIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
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
ACETAMINOPHENACETAMINOPHENPreferred Pharmaceuticals Inc.983debdf-4a61-4dde-ba34-567fdd17720e2026-06-11WarningsExact identifier
ndc (package): 68788-4132-3
ndc (package): 68788-4132-2
ndc (package): 68788-4132-1
ndc (package): 68788-4132-5
ndc (product): 68788-4132
ndc11 (package): 68788413205
ndc11 (package): 68788413202
ndc11 (package): 68788413203
ndc11 (package): 68788413201
spl id: 983debdf-4a61-4dde-ba34-567fdd17720e
spl set id: 983debdf-4a61-4dde-ba34-567fdd17720e

Reported adverse events (FAERS/openFDA)#

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