Topcare 8 Hour Pain Relief 650 mg/1
Acetaminophen · TABLET, FILM COATED, EXTENDED RELEASE · Topco Associates LLC
Topcare 8 Hour Pain Relief is a tablet, film coated, extended release containing acetaminophen at 650 mg/1, taken oral. Manufactured by Topco Associates LLC.
Key Facts
- Brand Name
- Topcare 8 Hour Pain Relief
- Generic Name
- Acetaminophen
- NDC Code (Product)
36800-369- Manufacturer
- Topco Associates LLC
- Strength
- 650 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA075077
- Marketing Start
- 04/05/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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
Dosage & Administration
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
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. Over…
Frequently Asked Questions
What is Topcare 8 Hour Pain Relief used for?
Topcare 8 Hour Pain Relief contains Acetaminophen. It is a tablet, film coated, extended release taken oral. Consult your doctor for specific uses.
Is Topcare 8 Hour Pain Relief a controlled substance?
Topcare 8 Hour Pain Relief is not classified as a controlled substance by the DEA.
What is the generic name for Topcare 8 Hour Pain Relief?
The generic name for Topcare 8 Hour Pain Relief is Acetaminophen. There are 12 other brand versions of Acetaminophen.
What is the NDC code for Topcare 8 Hour Pain Relief 650 mg/1?
The NDC (National Drug Code) for Topcare 8 Hour Pain Relief 650 mg/1 is 36800-369, listed by Topco Associates LLC.
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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)