FDA.reportPublic FDA data

Regular Strength Pain Reliever

Manufacturer
Spirit Pharmaceuticals LLC
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:42:38

Label at a glance#

ProductRegular Strength Pain Reliever
Active ingredientACETAMINOPHEN
Label structure10 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

Dosage and administration

do not take more than directed (see overdose warning) adults & children 12 years & 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 hour...

Storage and handling

• store between 20–25°C (68–77°F)

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

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: • the common cold • headache • 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.

OTC - DO NOT USE SECTION

Do not use• with any other drug containing acetaminophen (prescription or non prescription). 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 hasliver disease

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the user istaking 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.

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.

OVERDOSAGE 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 & children 12 years & 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 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

• store between 20–25°C (68–77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

Distributed By:
Spirit Pharmaceuticals, LLC
Ronkonkoma, NY 11779

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

APAP LabelAPAP Label

Carton

APAP CartonAPAP Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN4
313782acetaminophen 325 MG Oral TabletSCD4
313782APAP 325 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-5016-1Regular Strength Pain Reliever1 in 1 CARTONTABLET, FILM COATED14
68210-5016-1Regular Strength Pain Reliever60 in 1 BOTTLETABLET, FILM COATED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-5016REGULAR STRENGTH PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED [SPIRIT PHARMACEUTICALS LLC]42 package rows20241213_ebadbfc3-4329-4f23-979e-b4c2baaaf2a1.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68210-501668210-5016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PYRROLIDONEKKL5D39EOLIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ACETAMINOPHEN362O9ITL9DACTIB

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
2905480b-afd5-d9f2-e063-6294a90a9820ebadbfc3-4329-4f23-979e-b4c2baaaf2a12024-12-11WarningsExact identifier
spl id: 2905480b-afd5-d9f2-e063-6294a90a9820
spl set id: ebadbfc3-4329-4f23-979e-b4c2baaaf2a1

Reported adverse events (FAERS/openFDA)#

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