NYTOL HERBAL SIMPLY SLEEP ONE-A-NIGHT Film coated tablet Ref.[7373] Active ingredients: Valerian

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2016  Publisher: G. R. Lane Health Products Limited, Sisson Road, Gloucester, GL2 0GR, United Kingdom, Tel: +44 (0)1452 524012, Fax: +44 (0)1452 507930, Email: info@laneshealth.com

Product name and form

Kalms Night One-A-Night.

Nytol Herbal Simply Sleep One-A-Night Tablets.

Pharmaceutical Form

Film coated tablet.

White, ovaloid.

Qualitative and quantitative composition

Each tablet contains 385 mg of extract (as dry extract) from Valeriana officinalis L., radix (equivalent to 1.54–1.93 g of Valerian root).

Extraction solvent: Ethanol 60% V/V.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Valerian

Valerian is used as a hypnotic, anxiolytic and soothing agent since the oils it contains have a similar effect to benzodiazepines. Its mechanism of action, however, remains largely unknown.

List of Excipients

Extract excipients:

Maltodextrin
Colloidal anhydrous silica

Tablet Core:

Croscarmellose sodium
Magnesium stearate
Prosolv SMCC50 (silicified microcrystalline cellulose)
Talc
Silicon dioxide

Tablet Coating:

Opadry ™ 07F28588 white (hypromellose, talc, titanium dioxide, PEG, saccharin sodium)

Pack sizes and marketing

14, 21, 28, 42 or 56 tablets stored in PVC/Aclar-aluminium/polyethylene laminate blister packs.

Not all pack sizes may be marketed.

Marketing authorization holder

G. R. Lane Health Products Limited, Sisson Road, Gloucester, GL2 0GR, United Kingdom, Tel: +44 (0)1452 524012, Fax: +44 (0)1452 507930, Email: info@laneshealth.com

Marketing authorization dates and numbers

THR 01074/0002

05/03/2010

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