Otc - Purpose
Calms emotional outbursts and agitation and reduces mood swings
Moodcalm
FDA Label NDC 68703-018
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Silver Star Brands, Inc for the product Moodcalm (NDC 68703-018). 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 - purpose, otc - active ingredient, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, overdosage, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active Ingredients:Each dose contains equal parts of: Hyoscyamus 6C HPUS, Kali phos 6X HPUS, Nat sulphuricum 6X HPUS, Tarentula hisp 6C HPUS
Indications & Usage
Uses: Homeopathic remedy for acute agitation, restlessness or over excitement
Warnings
Warnings: If symptoms persist or worsen, consult a healthcare professional
Otc - Pregnancy Or Breast Feeding
If pregnant of breastfeeding, ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away
Dosage & Administration
Directions: For all ages: Take 2 tablets every 30 minutes. Serving may be repeated as needed for up to 10 servings. Alternatively, for small babies, crush tablets and sprinkle onto tongue. Special instructions: Avoid strong mint-flavored candy
Inactive Ingredient
Inactive Ingredients: Acacia gum, lactose, magnesium stearate, corn starch, sucrose
Information For Patients
The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com
Distributed by
Native Remedies, LLC
6531 Park of Commerce Blvd.
Siute 160
Boca Raton, FL 33487
Phone: +1.877.289.1235
International:+1.561.999.8857
Contains no artificial flavors or artificial colors. No gluten added
Storage And Handling
Tamper resistant for your protection. Use only if safety seal is intact.
Package Label.Principal Display Panel
Bottle Label (Mcm001)
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