Topcare 8 Hour Pain Relief
Acetaminophen · Tablet, Film Coated, Extended Release · Oral
Active ingredient
Active ingredient (in each caplet) Acetaminophen 650 mg
Purpose
Purpose Pain reliever/fever reducer
Uses
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
Warnings
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.
Do not use
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
Ask a doctor before use if you have liver disease
Ask a doctor or pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Stop use and ask a doctor
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.
Pregnancy or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children
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.
Directions
Directions
• do not take more than directed (see overdose warning) adults and children 12 years and over
• take 2 caplets every 8 hours with water
• swallow whole; do not crush, chew, split or dissolve
• do not take more than 6 caplets in 24 hours
• do not use for more than 10 days unless directed by a doctor children under 12 years
• do not use
Other information
Other information
• store at 20-25 ° C (68-77 ° F)
• do not use if printed foil under cap is broken or missing
• meets the requirements of USP Dissolution Test 4
Inactive ingredients
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
Questions?
Questions or comments? 1-888-423-0139
Label text from the FDA structured product label by Topco Associates LLC (revised May 13, 2025). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Acetaminophen in 1 product
Topcare 8 Hour Pain Relief NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 36800-369 | Acetaminophen 650 mg/1 Tablet, Film Coated, Extended Release | Topco Associates LLC | ANDA |
Frequently asked questions
What is Topcare 8 Hour Pain Relief used for?
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
Who makes Topcare 8 Hour Pain Relief?
Topcare 8 Hour Pain Relief is listed by 1 labeler in the FDA NDC directory, including Topco Associates LLC.