ACETAMINOPHEN

Manufacturer
NCS HealthCare of KY, LLC dba Vangard Labs
Effective date
2024-08-13
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
monthly-update
Hydrated at
2026-06-03 17:40:18

Label at a glance#

ProductACETAMINOPHEN Extra Strength
Active ingredientACETAMINOPHEN
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)
Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose
Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves minor aches and pains due to:

          • headache

          • the common cold

          • backache

          • minor pain of arthritis

          • toothache

          • muscular aches

          • premenstrual and menstrual cramps

  • temporarily reduces fever

WARNINGS SECTION

Warnings
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.

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 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

OTC - STOP USE SECTION

Stop using and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or last 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 (1-800-222-1222) right away. 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 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

SPL UNCLASSIFIED SECTION

Other information

  • SODIUM FREE
  • store between 20-25°C (68-77°F) excursions permitted between 15°-30°C (59°-86°F)
  • use by expiration date on package

INACTIVE INGREDIENT SECTION

Inactive ingredients hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
*may contain this ingredient

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

OTC - QUESTIONS SECTION

Manufactured by:

Time-Cap Labs, Inc

7 Michael Avenue

Farmingdale, NY 11735

341R 0922

PRINCIPAL DISPLAY PANEL - BINGO CARD

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 1284948334150acetaminophen-caplets-8409-1.jpg, acetaminophen-caplets-8409-2.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-341-01EA - Each49483-341235679f0-0eaa-47b9-899d-63526768600312016-12-07
49483-341-10EA - Each49483-34171d67bca-8711-4a54-a736-537e8c9e887e12022-02-07
49483-341-50EA - Each49483-3412a7fd6e7-9368-4aee-9196-b0ae222c383f12021-06-02

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0615-84090615-8409-39, 0615-8409-30, 0615-8409-05
49483-341

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 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
ACETAMINOPHEN Extra StrengthACETAMINOPHENTIME CAP LABS INCfd24d0e0-4f36-42d3-9149-2fb9576903052025-06-25WarningsExact identifier
ndc (product): 49483-341
e57e46f5-443b-469b-b046-aedeb83480347fae4caf-a8aa-442e-97ee-0465577bdb872024-08-13WarningsExact identifier
spl id: e57e46f5-443b-469b-b046-aedeb8348034
spl set id: 7fae4caf-a8aa-442e-97ee-0465577bdb87

Reported adverse events (FAERS/openFDA)#

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