FDA.reportPublic FDA data

Acetaminophen

Manufacturer
Kroger Company
Effective date
2018-12-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:38:42

Label at a glance#

ProductAcetaminophen
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and uses

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

Dosage and administration

• do not take more than directed (see overdose warning) adults and children 12 years and over • take 2 capsules every 4 to 6 hours while symptoms last • do not take more than 10 capsules in 24 hours • do not use for more than 10 days unless directed by a doctor children 6-11 years • take 1 capsule every 4 to 6 hours while symptoms last • do not take more than 5 capsules in 24 hours • do not use for more than 5 day...

Label contents#

Full prescribing information#

Active ingredient (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of 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 4,000 mg of acetaminophen 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • 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.

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 have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if the user

OTC - ASK DOCTOR SECTION

  • has liver disease
  • is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

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 (for adults) or 5 days (for children)
  • 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

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see overdose warning)

adults and

children 12 years

and over

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

children 6-11 years

  • take 1 capsule every 4 to 6 hours while symptoms last
  • do not take more than 5 capsules 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

  • do not use if printed seal under cap is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

edible ink*, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Questions or comments?

OTC - QUESTIONS SECTION

1-800-632-6900

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO the active ingredient of REGULAR STRENGTH TYLENOL®

See back panel

Acetaminophen

Pain Reliever/Fever Reducer

REGULAR STRENGTH

Contains No Aspirin

actual size

120 LIQUID GELS**

325 mg EACH

**LIQUID-FILLED CAPSULES

Acetaminophen Image
Acetaminophen Image

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-01830142-018-76, 30142-018-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT

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
8d1489fb-0043-4258-a7e0-ea9a612ff4c8f56f3b19-828e-42a3-bebf-061bf8caa2842020-12-03WarningsExact identifier
spl set id: f56f3b19-828e-42a3-bebf-061bf8caa284

Reported adverse events (FAERS/openFDA)#

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