FDA.reportPublic FDA data

Acetaminophen

Manufacturer
CVS Pharmacy, Inc.
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:02:57

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure10 sections

Indications and 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

Dosage and administration

■ do not take more than directed ■ adults and children 12 years and over: ■ take 2 tablets every 6 hours while symptoms last ■ do not take more than 6 tablets in 24 hours, unless directed by a doctor ■ do not take for more than 10 days unless directed by a doctor ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • 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

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.

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 a 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

OVERDOSAGE SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 6 hours while symptoms last

■ do not take more than 6 tablets in 24 hours, unless directed by a doctor

■ do not take for more than 10 days unless directed by a doctor

■ children under 12 years: ask a doctor

Other information

OTHER SAFETY INFORMATION

■ store in a dry place at 15°-30°C (59°-86°F)

■ see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

povidone, pregelatinized starch, sodium starch glycolate and stearic acid

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

READ AND KEEP CARTON FOR COMPLETE WARNINGS AND INFORMATION

*CVS is not affiliated with the owner of the registered trademark Tylenol® Extra Strength.

Distributed by: CVS Pharmacy, Inc.

One CVS Drive

Woonsocket, RI 02895

© 2025 CVS/pharmacy CVS.com®

1-800-SHOP CVS V-34571

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS

NDC 69842-465-12

Extra Strength

ACETAMINOPHEN

Pain Reliever, Fever Reducer, 500 mg

Compare to Tylenol® Extra Strength active ingredient*

100 TABLETS

Contains No Aspirin

For Adults

CVS LabelCVS Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN5
198440acetaminophen 500 MG Oral TabletSCD5
198440APAP 500 MG Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-465-12Acetaminophen1 in 1 CARTONTABLET15
69842-465-12Acetaminophen100 in 1 BOTTLETABLET1005

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
69842-46569842-465-12

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
STARCH, PREGELATINIZED CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
ACETAMINOPHEN362O9ITL9DACTIB
POVIDONEFZ989GH94EIACT
SODIUM STARCH GLYCOLATE TYPE A POTATO5856J3G2A2IACT

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
AcetaminophenACETAMINOPHENCVS Pharmacy, Inc.6dea9e11-ff99-63c7-e053-2a91aa0a5b542025-06-10WarningsExact identifier
ndc (package): 69842-465-12
ndc (product): 69842-465
ndc11 (package): 69842046512
spl id: 373dfe36-0549-5035-e063-6394a90ac1df
spl set id: 6dea9e11-ff99-63c7-e053-2a91aa0a5b54

Reported adverse events (FAERS/openFDA)#

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