Topcare 8 Hour Pain Relief
Topco Associates LLC. 8 Hour Pain Relief Drug Facts
38abe710-3d8a-41b0-b057-38c5dfd53322
HUMAN OTC DRUG LABEL
May 13, 2025
Topco Associates LLC
DUNS: 006935977
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 (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Package/Label Principal Display Panel
TopCare® health
COMPARE TO TYLENOL® 8HR ACTIVE INGREDIENT
8 HR Pain Relief
ACETAMINOPHEN EXTENDED-RELEASE TABLETS, 650 mg
PAIN RELIEVER • FEVER REDUCER
8 HOUR
For up to 8 Hours Relief of Minor Muscle Aches and Pain
actual size
100 CAPLETS† - 650 mg EACH
†CAPSULE-SHAPED TABLETS
INDICATIONS & USAGE SECTION
Uses
•
temporarily relieves minor aches and pains due to:
•
muscular aches
•
backache
•
minor pain of arthritis
•
toothache
•
premenstrual and menstrual cramps
•
headache
•
the common cold
•
temporarily reduces fever
OTC - ACTIVE INGREDIENT SECTION
Active ingredient (in each caplet)
Acetaminophen 650 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 6 caplets 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.
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
Ask a doctor before use if you have
liver disease
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
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.
If pregnant or breast-feeding,
ask a health professional before use.
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 |
• |
STORAGE AND HANDLING SECTION
Other information
•
store at 20-25°C (68-77°F)
•
**do not use if printed foil under cap is broken or missing**
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meets the requirements of USP Dissolution Test 4
INACTIVE INGREDIENT SECTION
Inactive ingredients
carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-888-423-0139