Henry Schein Acetaminophen

Manufacturer
Henry Schein, Inc. | Unifirst First Aid Corporation | Prestige Packaging
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:13:22

Label at a glance#

ProductHenry Schein Acetaminophen
Active ingredientACETAMINOPHEN
Label structure8 sections

Indications and uses

For the temporary relief of minor aches and pains associated with headache common cold muscular aches toothache minor arthritis pain menstrual cramps For the reduction of fever.

Dosage and administration

do not use more than directed Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. Do not give to children under 12 years of age.

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

For the temporary relief of minor aches and pains associated with

  • headache
  • common cold
  • muscular aches
  • toothache
  • minor arthritis pain
  • menstrual cramps

For the reduction of fever.

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED SECTION

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

  • more than 12 tablets in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert:

SPL UNCLASSIFIED SECTION

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.
  • for more than 10 days for pain unless directed by a doctor
  • for more than 3 days for fever unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not improve
  • new symptoms occur
  • pain or fever persists or gets worse
  • redness or swelling is present
OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of accidental overdose, get medical help or contact a Poison Control Center 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 use more than directed

Adults and children:(12 years and older)

SPL UNCLASSIFIED SECTION

Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children under 12 years:

SPL UNCLASSIFIED SECTION

Do not give to children under 12 years of age.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 59°-86°F (15°-30°C)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? 1-800-472-4346

Henry Schein Actaminophen 325 mg Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Henry Schein®

Acetaminophen

For the temporary relief of minor aches and pains
associated with the headache, muscular aches, minor arthritis pain,
common cold, toothache, menstrual cramps and for the reduction of fever.

Henry Schein Seal of Excellence®

Pull to Open

Reorder

900-4689

Acetaminophen 325 mg

250 Packets/2 Tablets

Henry Schein label 2Henry Schein label 2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313782acetaminophen 325 MG Oral TabletPSN10
313782acetaminophen 325 MG Oral TabletSCD10
313782APAP 325 MG Oral TabletSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0714-13Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED210
0404-0714-13Henry Schein Acetaminophen250 in 1 BOXTABLET, FILM COATED25010
0404-0714-99Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED210

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1A2
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-07140404-0714-99, 0404-0714-13

Ingredients#

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

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

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Henry Schein AcetaminophenACETAMINOPHENHenry Schein, Inc.f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa2025-09-08WarningsExact identifier
ndc (package): 0404-0714-13
ndc (package): 0404-0714-99
ndc (product): 0404-0714
ndc11 (package): 00404071499
ndc11 (package): 00404071413
spl id: 3e4c6f6c-2c41-2312-e063-6394a90a03f3
spl set id: f43f72de-ff79-4c7e-bd1e-3f0c4c3872fa

Reported adverse events (FAERS/openFDA)#

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