Controlled Substance
Chloral Hydrate
Chloralum
FDA Label NDC 10191-1177
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Remedy Makers for the product Chloralum (NDC 10191-1177). 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 controlled substance, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
INSOMNIA, EXCITABILITY, OR OTHER INDICATIONS
Otc - Keep Out Of Reach Of Children
WARNING: Keep this and all medications out of reach of children.
Indications & Usage
INDICATIONS: To be used according to standard homeopathic indications for self limiting conditions such as those indicated on the front panel or as directed by a physician.
Free from yeast, wheat, corn, and soy.
Warnings
WARNING: Used only if cap and seal are unbroken. If symptoms persist for more then 3 days, consult your physician. As with any drug, if your pregnant or nursing a baby, seek the advise of a health professional before using this product. Store tightly closed in a cool, dark place. Made according to The Homeopathic Pharmacopoeia of the United State by: Remedy Makers, Pomona, CA 91768.
Dosage & Administration
DIRECTION: Dissolve 3 or 4 in mouth or tongue 3 times a day or as directed by a physician. Children 2 years and older take 1/2 adult dose.
Inactive Ingredient
80% SUCROSE / 20% LACTOSE
Package Label.Principal Display Panel
Chloralum3x (Cb9872ce 3f3a 4b40 99e2 9434feb7226a)
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