Henry Schein Acetaminophen

Manufacturer
Henry Schein, Inc. | Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:13:17

Label at a glance#

ProductHenry Schein Acetaminophen
Active ingredientACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Acetaminophen 500 mg

OTC - PURPOSE SECTION

Purpose

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • muscular aches
  • minor pain of arthritis
  • backache
  • the common cold
  • toothache
  • premenstrual and menstrual cramps

temporarily reduces fever

WARNINGS SECTION

Warnings

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

  • more than 4,000 mg 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:

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 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

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 for 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.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

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

​Adults and children: (12 years and older)

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

Children under 12 years: Ask a doctor

SPL UNCLASSIFIED SECTION

Other information

  • store at room temperature 59º-86ºF (15º-30ºC)
  • tamper-evident sealed packets
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

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 XS Acetaminophen Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC #0404-0716-13

Henry Schein®

Extra Strength 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®

This Package is for Households without Young Children.

Acetaminophen 500 mg

250 Packets/2 Tablets

Reorder

900-4690

HenryHenry

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN11
198440acetaminophen 500 MG Oral TabletSCD11
198440APAP 500 MG Oral TabletSY11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0716-13Henry Schein Acetaminophen250 in 1 BOXTABLET, FILM COATED25011
0404-0716-99Henry Schein Acetaminophen2 in 1 PACKETTABLET, FILM COATED211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
POVIDONEINACTIVE INGREDIENTFZ989GH94E2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0404-07160404-0716-99, 0404-0716-13

Ingredients#

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

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

Source Document#

Source XML

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
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
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 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
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 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
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
POVIDONEPOVIDONEFZ989GH94ETABLET, FILM COATED / ORAL240 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
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 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
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 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.a56a5ca1-578c-40cd-90cc-cc4c2dfec8472025-09-08WarningsExact identifier
ndc (package): 0404-0716-99
ndc (package): 0404-0716-13
ndc (product): 0404-0716
ndc11 (package): 00404071613
ndc11 (package): 00404071699
spl id: 3e4c6e10-f9dd-1bca-e063-6294a90a78e1
spl set id: a56a5ca1-578c-40cd-90cc-cc4c2dfec847

Reported adverse events (FAERS/openFDA)#

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