Medique at Home APAP Extra Strength
Medique @ Home APAP Extra Strength
b56b4110-fb8f-e5a0-e053-2995a90a0ad3
HUMAN OTC DRUG LABEL
Aug 19, 2025
Unifirst First Aid Corporation
DUNS: 832947092
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen 500 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (9)
Acetaminophen 500 mg
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (8)
Drug Labeling Information
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
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
OTC - QUESTIONS SECTION
Questions or comments? 1-800-634-7680
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - PURPOSE SECTION
Puropse
Pain reliever/fever reducer
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each tablet)
Acetaminophen 500 mg
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 ifyou 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.
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
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
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