FDA.reportPublic FDA data

ACETAMINOPHEN

Manufacturer
Rapid Care, Inc
Effective date
2022-04-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:15

Label at a glance#

ProductACETAMINOPHEN
Active ingredientACETAMINOPHEN
Label structure14 sections

Indications and 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

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 500mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer

USES

INDICATIONS & USAGE SECTION

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

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 4,000mg 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.

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.

OTC - DO NOT USE SECTION

Do not use  

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether 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 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
  • You may report side effects to 1-888-952-0050

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.

DOSAGE & ADMINISTRATION SECTION

Directions

do not take more than directed (see overdose warning)

Adults and children 12 years and over

  • take 2 tablets every 6 hours while symptoms last
  • do not take more than 8 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 of age

  • ask a doctor

Other information

OTHER SAFETY INFORMATION

store between 20º-25ºC (68º-77ºF)

INACTIVE INGREDIENT SECTION

corn starch, hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid, titanium dioxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel2label2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73659-013-012024-01-30C16284748780-11030e365-2728-111a-e063-dadaa90a10e2RapidCare Pain Reliever
73659-013-022024-01-30C16284748780-11030e365-2728-111a-e063-dadaa90a10e2RapidCare Pain Reliever

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73659-013-01ACETAMINOPHEN2 in 1 POUCHTABLET21
73659-013-01ACETAMINOPHEN50 in 1 BOXTABLET501
73659-013-02ACETAMINOPHEN125 in 1 BOXTABLET1251
73659-013-02ACETAMINOPHEN2 in 1 POUCHTABLET21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73659-013ACETAMINOPHEN TABLET [RAPID CARE, INC]1Legacy NDC, 4 package rows20220420_dcf51de4-fadc-81da-e053-2a95a90a3173.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73659-01373659-013-01, 73659-013-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
HYPROMELLOSES3NXW29V3WOIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT

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
dcf51de4-fadd-81da-e053-2a95a90a3173dcf51de4-fadc-81da-e053-2a95a90a31732022-04-18WarningsExact identifier
spl id: dcf51de4-fadd-81da-e053-2a95a90a3173
spl set id: dcf51de4-fadc-81da-e053-2a95a90a3173

Reported adverse events (FAERS/openFDA)#

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