Sleep HP

Sleep HP is an FDA-registered drug product whose active ingredient is ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS. It is labelled by Grato Holdings, Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 70163-0002, label effective 20201130. It is one of 2 FDA drug label records sharing the active ingredient ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS. 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 ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS are most often described in connection with: temporary relieve, symptoms due, inability sleep, claims based, traditional homeopathic, accepted medical, fda evaluated. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS: May temporary relieve symptoms due to fatigue and restlessness from inability to sleep.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

DIRECTIONS: Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

FDA lists 2 drug label records with ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS 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 Sleep HP used for?
INDICATIONS: May temporary relieve symptoms due to fatigue and restlessness from inability to sleep.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Who makes Sleep HP?
Grato Holdings, Inc. is the labeler of record for Sleep HP. 2 FDA label records share the active ingredient ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS, 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 Sleep HP 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 Sleep HP 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 ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS?
Yes. 2 FDA drug label records list ARSENICUM ALBUM, AVENA SATIVA, COFFEA CRUDA, KALI CARBONICUM, MAGNESIA CARBONICA, NUX VOMICA, PASSIFLORA INCARNATA, SEPIA, VALERIANA OFFICINALIS 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 Sleep HP 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.