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 01:48:10

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure13 sections

Indications and uses

temporarily relieves minor aches and pains due to: the common cold  headache  backache minor pain from arthritis  toothache  muscular aches premenstrual and menstrual cramps temporarily reduces fever

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 caplet)                                    Purpose

Acetaminophen USP, 500 mg........................................Pain Reliever/Fever Reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • the common cold 
  • headache 
  • backache
  • minor pain from 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

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
  • 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: 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.

DOSAGE & ADMINISTRATION SECTION

aceta-500mg-directionsaceta-500mg-directions

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 or comments? Call 1-844-474-7464

†This product is neither manufactured nor distributed by the owner of the registered trademark Tylenol® Extra Strength.

Distributed by:
Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Made in India

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

Revised: 10/2025

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
198440acetaminophen 500 MG Oral TabletPSN1
198440acetaminophen 500 MG Oral TabletSCD1
198440APAP 500 MG Oral TabletSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1285723734705acetaminophen-caplets-8610-2.jpg, acetaminophen-caplets-8610-3.jpg
Data codeCode 128572373470539acetaminophen-caplets-8610-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8610-05Acetaminophen15 in 1 BLISTER PACKTABLET, FILM COATED151
0615-8610-30Acetaminophen5 in 1 BLISTER PACKTABLET, FILM COATED51
0615-8610-30Acetaminophen6 in 1 BOX, UNIT-DOSETABLET, FILM COATED61
0615-8610-39Acetaminophen30 in 1 BLISTER PACKTABLET, FILM COATED301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-347-01EA - Each57237-3474f6789ab-9c2c-4ac7-a464-2a6e97d0c88b12025-08-11
57237-347-05EA - Each57237-34787c5b2bc-2c08-4480-8a77-b1524ea59b1312025-11-13

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
0615-86100615-8610-39, 0615-8610-05, 0615-8610-30
57237-347

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 Labsf32fc2e9-c0e3-4a25-8399-9cdba6ae8a162026-02-26WarningsExact identifier
ndc (package): 0615-8610-30
ndc (package): 0615-8610-39
ndc (package): 0615-8610-05
ndc (product): 0615-8610
ndc11 (package): 00615861005
ndc11 (package): 00615861039
ndc11 (package): 00615861030
spl id: 4e18d785-6ccf-4f42-b6bc-e8ff4364e149
spl set id: f32fc2e9-c0e3-4a25-8399-9cdba6ae8a16
AcetaminophenACETAMINOPHENRising Pharma Holdings, Inc.f8237772-7656-49fb-b1de-f8fcb5fa55ee2025-10-28WarningsExact identifier
ndc (product): 57237-347

Reported adverse events (FAERS/openFDA)#

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