Acetaminophen

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs | Elysium Pharmaceuticals Ltd
Effective date
2026-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:47:32

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and uses

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

Dosage and administration

Do not take more than directed Adults and Children 12 years and over: take 2 tablets every 4 to 6 hours while symptoms last. do not take more than 10 tablets in 24 hours. do not take for more than 10 days unless directed by a doctor Children 6 years to under 12 years: take 1 tablet every 4 to 6 hours while symptoms last. do not take more than 5 tablets in 24 hours. do not use for more than 5 days unless directed b...

Label contents#

Full prescribing information#

DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)                          Purpose
Acetaminophen USP, 325 mg.................................Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

To reduce fever and for the temporary relief of minor aches and
pains due to:

  • headache 
  • muscular aches
  • backache
  • minor pain from arthritis 
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever.

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen.

Severe liver damage may occur if

  • adult takes more than 10 tablets in 24 hours, which is the maximum daily amount 
  • child takes more than 5 tablets in 24 hours 
  • taken with other drugs containing acetaminophen
  • adult has 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 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.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have liver disease.

OTC - ASK DOCTOR/PHARMACIST SECTION

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 in adults and children.
• pain gets worse or lasts more than 5 days in children under 12 years.
• 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.
Overdose warning:
Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt 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
Adults and Children 12 years and over:

  • take 2 tablets every 4 to 6 hours while symptoms last.
  • do not take more than 10 tablets in 24 hours.
  • do not take for more than 10 days unless directed by a doctor

Children 6 years to under 12 years:

  • take 1 tablet every 4 to 6 hours while symptoms last.
  • do not take more than 5 tablets in 24 hours.
  • do not use for more than 5 days unless directed by a doctor

Children under 6 years:
ask a doctor

Other Information

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • see end panel for lot number and expiration date.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, talc, titanium dioxide.

OTC - QUESTIONS SECTION

Questions and Comments? Call 1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

Mfg. Lic. No.: G/25/2258

Issued: 07/2025 (S-069-00)

†This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, owner of the registered trademark Tylenol® Regular strength.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - BINGO CARD

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - UNIT DOSE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN1
313782acetaminophen 325 MG Oral TabletSCD1
313782APAP 325 MG Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1285723734610acetaminophen-tabs-8608-8609-2.jpg, acetaminophen-tabs-8608-8609-1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8608-05Acetaminophen15 in 1 BLISTER PACKTABLET, FILM COATED151
0615-8608-30Acetaminophen6 in 1 BOX, UNIT-DOSETABLET, FILM COATED61
0615-8608-30Acetaminophen5 in 1 BLISTER PACKTABLET, FILM COATED51
0615-8608-39Acetaminophen30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-346-01EA - Each57237-3462ccb0212-ce31-48f1-bb7c-e48bd05936bd12025-08-11
57237-346-10EA - Each57237-34639d36403-64f2-4dbf-ad05-c27fd026367a12025-11-13

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-86080615-8608-39, 0615-8608-05, 0615-8608-30
57237-346

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labs1f4ac0e6-e986-4c22-8248-0691d64e1a302026-02-26WarningsExact identifier
ndc (package): 0615-8608-39
ndc (package): 0615-8608-05
ndc (package): 0615-8608-30
ndc (product): 0615-8608
ndc11 (package): 00615860830
ndc11 (package): 00615860839
ndc11 (package): 00615860805
spl id: 7424cb7d-be03-4957-8e5c-976a13aa811a
spl set id: 1f4ac0e6-e986-4c22-8248-0691d64e1a30
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.bd5e6804-4df4-4a65-92e4-faa3a0f7c0052025-07-22WarningsExact identifier
ndc (product): 57237-346

Reported adverse events (FAERS/openFDA)#

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