ACETAMINOPHEN

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2024-08-19
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:17:23

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)
Acetaminophen 325 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings
Liver Warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children.  Severe liver damage may occur if:

  • adult takes more than 4,000 mg of acetaminophen in 24 hours.
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 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.

OTC - DO NOT USE SECTION

Do not use

  • 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 the user has liver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user

is taking the blood thinning drug warfarin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more then 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: 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.

DOSAGE & ADMINISTRATION SECTION

Directions

  •  do not take more than directed

   See overdose warning

 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, unless directed by a doctor
  • do not use 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

SPL UNCLASSIFIED SECTION

  • SODIUM FREE
  • store at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients
povidone, pregelatinized starch, sodium starch glycolate*, stearic acid
*may contain this ingredient

SPL UNCLASSIFIED SECTION

Questions or comments? call 1-877-290-4008

Manufactured by: Time-Cap Labs, Inc.,

7 Michael Avenue, Farmingdale, NY 11735

340R 1022

PRINCIPAL DISPLAY PANEL- BINGO

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL

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 TabletPSN11
313782acetaminophen 325 MG Oral TabletSCD11
313782APAP 325 MG Oral TabletSY11

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1284948334010acetaminophen-tabs-325-mg-8397-2.jpg
Data codeCode 128494833401030acetaminophen-tabs-325-mg-8397-2.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8397-05ACETAMINOPHEN15 in 1 BLISTER PACKTABLET1511
0615-8397-30ACETAMINOPHEN5 in 1 BLISTER PACKTABLET511
0615-8397-30ACETAMINOPHEN6 in 1 BOX, UNIT-DOSETABLET611
0615-8397-39ACETAMINOPHEN30 in 1 BLISTER PACKTABLET3011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-340-01EA - Each49483-34024193a13-9584-4d37-9512-ed41d3dd4b7c12016-12-07
49483-340-10EA - Each49483-340cd27a4fd-0234-4d68-9429-662a87a6322212021-05-05

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-83970615-8397-39, 0615-8397-30, 0615-8397-05
49483-340

Ingredients#

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

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102024-08-19full-release2026-06-01 00:17:52

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
ACETAMINOPHENACETAMINOPHENTIME CAP LABS INCc193dbc0-cc80-4a7c-aa29-457a20edf8352025-02-08WarningsExact identifier
ndc (product): 49483-340
ACETAMINOPHENACETAMINOPHENNCS HealthCare of KY, LLC dba Vangard Labsbb450552-728a-4675-b0a9-0fd2934f6c5e2024-08-19WarningsExact identifier
ndc (package): 0615-8397-30
ndc (package): 0615-8397-05
ndc (package): 0615-8397-39
ndc (product): 0615-8397
ndc11 (package): 00615839705
ndc11 (package): 00615839730
ndc11 (package): 00615839739
spl id: d48fadc8-c402-4ecd-b8af-c1ea069eac71
spl set id: bb450552-728a-4675-b0a9-0fd2934f6c5e

Reported adverse events (FAERS/openFDA)#

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