Medique at Home APAP Extra Strength

Manufacturer
Unifirst First Aid Corporation
Effective date
2025-09-08
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:13:01

Label at a glance#

ProductMedique at Home APAP Extra Strength
Active ingredientACETAMINOPHEN
Label structure17 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

Puropse

Pain reliever/fever reducer

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

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 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 more than 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 over ■ take 2 tablets every 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

OTHER SAFETY INFORMATION

Other information

■ store at room temperature 59º-86ºF (15º-30ºC)

■ TAMPER EVIDENT child resistant packets

■ do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

* may contain

OTC - QUESTIONS SECTION

Questions or comments? 1-800-634-7680

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique® @ Home

APAP Extra Strength Tablets

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Pull to Open

Child-Resistant Packets

*not the actual size

50 Packets

(2 Tablets Per Packet)

Compare to the active ingredient in Extra Strength Tylenol® Tablets

2 MDQ2 MDQ

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medique® @ Home

APAP Extra Strength Tablets

Acetaminophen 500 mg

Pain Reliever/Fever Reducer

Pull to Open

Child-Resistant Packets

*not the actual size

50 Packets

(2 Tablets Per Packet)

Compare to the active ingredient in Extra Strength Tylenol® Tablets

MDQ APAPMDQ APAP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198440acetaminophen 500 MG Oral TabletPSN10
198440acetaminophen 500 MG Oral TabletSCD10
198440APAP 500 MG Oral TabletSY10

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47682-043-33Medique at Home APAP Extra Strength50 in 1 BOXTABLET, FILM COATED5010
47682-043-33Medique at Home APAP Extra Strength2 in 1 PACKETTABLET, FILM COATED210
47682-433-33Medique at Home APAP Extra Strength50 in 1 BOXTABLET, FILM COATED5010
47682-433-99Medique at Home APAP Extra Strength2 in 1 PACKETTABLET, FILM COATED210

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47682-43347682-433-99, 47682-433-33
47682-04347682-043-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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
Medique at Home APAP Extra StrengthACETAMINOPHEN 500 MGUnifirst First Aid Corporationb56b4110-fb8f-e5a0-e053-2995a90a0ad32025-09-08WarningsExact identifier
ndc (package): 47682-433-33
ndc (package): 47682-433-99
ndc (package): 47682-043-33
ndc (product): 47682-433
ndc (product): 47682-043
ndc11 (package): 47682043333
ndc11 (package): 47682043399
ndc11 (package): 47682004333
spl id: 3e4fc1dc-5e1c-e21d-e063-6294a90a5ee4
spl set id: b56b4110-fb8f-e5a0-e053-2995a90a0ad3

Reported adverse events (FAERS/openFDA)#

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