CAREONE

CAREONE is an FDA-registered drug product whose active ingredient is PSYLLIUM HUSK. It is labelled by FOODHOLD USA taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41520-907, application M007, label effective 20260811. It is one of 8 FDA drug label records sharing the active ingredient PSYLLIUM HUSK. 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 PSYLLIUM HUSK are most often described in connection with: effective treating, occasional constipation, restoring regularity, product generally, produces bowel, movement hours. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses ▪ effective in treating occasional constipation and restoring regularity. ▪ This product generally produces bowel movement in 12 to 72 hours.

Directions ▪ Take this product with at least 8 ounces (a full glass) of water or other fluid. Taking this product without enough liquid may cause choking. See choking warning. ▪ Adults 12 years and older: 5 capsules with at least 8 oz. of liquid (swallow 1 capsule at a time) at the first sign of irregularity. Can be taken up to 3 times daily. ▪ children 12 years and under: Ask a doctor ▪ Laxatives, including bulk fibers, may affect how well other medicines work. If you are taking a prescription medication by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. ▪ As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

Warnings Choking Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Allergy alert This product may cause allergic reaction in people sensitive to inhaled or ingested psyllium. Ask a doctor before use if you have ▪ a sudden change in bowel habits persisting for 2 weeks ▪ abdominal pain, nausea or vomiting Stop use and ask a doctor if ▪ constipation lasts more than 7 days ▪ rectal bleeding occurs These may be signs of a serious condition. Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

FDA lists 8 drug label records with PSYLLIUM HUSK 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.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is CAREONE used for?
Uses ▪ effective in treating occasional constipation and restoring regularity. ▪ This product generally produces bowel movement in 12 to 72 hours.

Who makes CAREONE?
FOODHOLD USA is the labeler of record for CAREONE. 8 FDA label records share the active ingredient PSYLLIUM HUSK, 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 CAREONE 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 CAREONE 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 PSYLLIUM HUSK?
Yes. 8 FDA drug label records list PSYLLIUM HUSK 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 CAREONE been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

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.