Active Ingredients:
(in each drop): 11.11% of Arsenicum Album 30X, Avena Sativa 30X, Coffea Cruda 30X, Kali Carbonicum 30X, Magnesia Carbonica 30X, Nux Vomica 30X, Passiflora Incarnata 30X, Sepia 30X, Valeriana Officinalis 30X.
Sleep Hp Liquid
FDA Label NDC 70163-0002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Grato Holdings, Inc. for the product Sleep Hp (NDC 70163-0002). 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 active ingredients:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications:
May temporary relieve symptoms due to fatigue and restlessness from inability to sleep.**
**Claims based on traditional homeopathic practice. Not FDA evaluated.
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.
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.
Keep Out Of Reach Of Children:
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
Inactive Ingredients:
Demineralized water, 20% Ethanol.
Questions:
Dist. by Grato Holdings, Inc.
201 Apple Blvd.
Woodbine, IA 51579 800-869-8078
Package Label Display:
ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
SLEEP HP
1 fl. oz. (30 ml)
Sleep Hp (Gthd0001 Sleep Hp)
* Please review the disclaimer below.
