Pain Relief 650 mg/1
Pain Relief · TABLET, EXTENDED RELEASE · Allegiant Health
Pain Relief is a tablet, extended release containing pain relief at 650 mg/1, taken oral. Manufactured by Allegiant Health.
Key Facts
- Brand Name
- Pain Relief
- Generic Name
- Pain Relief
- NDC Code (Product)
69168-461- Manufacturer
- Allegiant Health
- Strength
- 650 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA211544
- Marketing Start
- 04/24/2024
Recall History
Ridge Properties, LLC
Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
Ridge Properties, LLC
GMP Deviations: inadequate manufacturing control processes
Ridge Properties, LLC
Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
AVKARE LLC
Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% Prescription Dental Toothpaste
Unexo Life Sciences Private Limited
cGMP Deviations
The Mentholatum Co.
Labeling: Incorrect Instructions; The word not is missing from the following sentences "do bandage tightly or cover with any type of wrap except clothing and "do use with a heating pad or with other heat sources in the Drug Facts panel "Warning" section
Ridge Properties, LLC
GMP Deviations: inadequate manufacturing control processes
Unexo Life Sciences Private Limited
cGMP Deviations
Ultra Seal Corporation
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
US Pharmaceuticals Inc.
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Side 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: the common cold headache backache minor pain of arthritis toothache muscular aches premenstrual and menstrual cramps 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 6 hours while symptoms last do not take more than 6 caplets 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
Warnings
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. 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 medica…
Frequently Asked Questions
What is Pain Relief used for?
Pain Relief contains Pain Relief. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Pain Relief a controlled substance?
Pain Relief is not classified as a controlled substance by the DEA.
What is the generic name for Pain Relief?
The generic name for Pain Relief is Pain Relief. There are 12 other brand versions of Pain Relief.
What is the NDC code for Pain Relief 650 mg/1?
The NDC (National Drug Code) for Pain Relief 650 mg/1 is 69168-461, listed by Allegiant Health.
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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)