Otc - Active Ingredient
Active ingredients (each 5X HPUS): Cherry Plum, Clematis, Impatiens, Rock Rose, Star of Bethlehem, White Chestnut. ‘HPUS’ indicates ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Rescue Sleep Pastilles Blackcurrant Lozenge
FDA Label NDC 57687-320
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Nelson Bach Usa Ltd for the product Rescue Sleep Pastilles Blackcurrant (NDC 57687-320). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, dosage & administration, other safety information, storage and handling, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Purpose/Use: For relief of occasional sleeplessness caused by stress & repetitive thoughts
Warnings
Warnings: Stop using & ask a doctor if sleeplessness persists for more than 2 weeks: insomnia can be a symptom of a serious underlying medical illness. Excessive consumption may induce a mild laxative effect. If pregnant or breastfeeding, ask a doctor before use. Keep out of reach of children. Product can pose a choking hazard.
Dosage & Administration
Directions: Adults & children aged 6 & older, consume 1 pastille & completely dissolve before sleep. Do not go to sleep with undissolved pastille in mouth
Other Safety Information
Other information: Do not use if tamper-evident seal is missing or broken.
FOR HUMAN CONSUMPTION ONLY, NOT FOR ANIMAL USE.
Storage And Handling
Store below 77°F
Inactive Ingredient
Inactive ingredients: beeswax, black carrot extract, black currant (as flavor), citric acid, elder extract, gum arabic, isomalt, maltitol, red cabbage extract, sorbitol, sustainable palm kernel oil, xylitol.
Otc - Questions
RESCUE SLEEP® is a homeopathic dilution: see NelsonsDilution.com for details. Trademarks on pack are owned by the Nelsons’ Group. Questions: (800) 319-9151. Nelsons.com. Dist by: Nelson Bach USA Ltd, N. Andover, MA 01845. Made in Switzerland. Made in an FDA registered pharmaceutical facility. aims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. Product can pose a choking hazard
Otc - Purpose
Active ingredients (each 5X HPUS): Cherry Plum, Clematis, Impatiens, Rock Rose, Star of Bethlehem, White Chestnut. ‘HPUS’ indicates ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Package Label.Principal Display Panel
NDC 57687-320-50
Bach Original Flower Essences
Rescue Sleep Pastilles - Blackcurrant flavour
Nighttime sleep aid
with natural bach flower essences
Homeopathic
1.7 oz (50g)
35 pastilles
see disclaimer on back panel
* Please review the disclaimer below.
