8 HR Arthritis Pain

8 HR Arthritis Pain is an FDA-registered drug product whose active ingredient is ACETAMINOPHEN. It is labelled by Dr. Reddy's Laboratories Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 75907-430, application ANDA211544, label effective 20260701. It is one of 274 FDA drug label records sharing the active ingredient ACETAMINOPHEN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ACETAMINOPHEN are most often described in connection with: temporarily relieves, minor aches, pains due, pain arthritis, backache premenstrual, menstrual cramps, common cold, headache toothache. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

USES • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever

DIRECTIONS • do not take more than directed (see overdose warning) adults • 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 under 18 years of age • ask a doctor

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 everyday 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

FDA lists 274 drug label records with ACETAMINOPHEN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is 8 HR Arthritis Pain used for?
USES • temporarily relieves minor aches and pains due to: • minor pain of arthritis • muscular aches • backache • premenstrual and menstrual cramps • the common cold • headache • toothache • temporarily reduces fever

Who makes 8 HR Arthritis Pain?
Dr. Reddy's Laboratories Inc. is the labeler of record for 8 HR Arthritis Pain. 274 FDA label records share the active ingredient ACETAMINOPHEN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does 8 HR Arthritis Pain come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is 8 HR Arthritis Pain prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ACETAMINOPHEN?
Yes. 274 FDA drug label records list ACETAMINOPHEN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has 8 HR Arthritis Pain been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.