careone acetaminophen
American Sales Company Acetaminophen Drug Facts
4bb696f6-a47b-4da9-9224-9aeae3e152f3
HUMAN OTC DRUG LABEL
Sep 19, 2025
American Sales Company
DUNS: 809183973
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
CAREone®
Compare to the active ingredient in Tylenol® Extra Strength Rapid Release Gels
Extra Strength
ACETAMINOPHEN
500mg
Actual Size
Pain Reliever/Fever Reducer
Rapid Release
For Adults
Gluten Free
100 CAPLETS
INDICATIONS & USAGE SECTION
Uses
•
temporarily relieves minor aches and pains due to:
•
the common cold
•
headache
•
minor pain of arthritis
•
backache
•
muscular aches
•
toothache
•
premenstrual and menstrual cramps
•
temporarily reduces fever
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 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 - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 500 mg
OTC - PURPOSE SECTION
Purpose
Pain reliever/fever reducer
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 have ever had an allergic reaction to this product or any of its ingredients
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you have
liver disease
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 take more than directed (see overdose warning)**
|
adults and children 12 years and over |
• • • |
|
children under 12 years |
ask a doctor |
STORAGE AND HANDLING SECTION
Other information
•
store at 20-25°C (68-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredients
croscarmellose sodium, crospovidone, FD&C red #40 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, mica-based pearlescent pigment, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid
OTC - QUESTIONS SECTION
Questions or comments?
1-800-719-9260