Active Ingredient
PASSIFLORA INCARNATA HPUS 3X and higher
KALI PHOSPHORICUM HPUS 1X and Higher
Rxhomeo Homeopathic Combo
FDA Label NDC 15631-2483
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rxhomeo Private Limited D.b.a. for the product Rxhomeo Homeopathic Combo (NDC 15631-2483). 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 ingredient, uses, indications, dosage, warnings, otc - stop use, otc - keep out of reach of children, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
A homeopathic combination pack with two single remedies Passiflora Incarnata and Kali Phosphoricum for relief of sleeplessness.
Passiflora Incarnata; Uses: Passiflora Incarnata is a chief remedy for insomnia or sleeplessness. Passiflora helps in quietning the nervous system and induces normal sleep. Restlessness and wakeful sleep especially in the feeble, infants, and the aged with history of mental worries and over work.
Kali Phosphoricum;Uses: Kali Phosphoricum helps in insomnia or sleeplessness after worry or excitement from nervous causes. Also walking in sleep in children.
Indications
Condition listed above or as directed by the physician
Dosage
PELLETS included in the Combo
Adults- Take 4 or 6 Pellets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
TABLETS included in the Combo
Adults- Take 4 or 6 Tablets by mouth, three times daily or as suggested by physician. Children 2 years and older- take 1/2 the adult dose.
Warnings
This product is to be used for self-limiting conditions
Otc - Stop Use
If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional
Otc - Keep Out Of Reach Of Children
Keep this and all medication out of reach of children
Otc - Do Not Use
Do not use if capseal is broken or missing.
Close the cap tightly after use.
Inactive Ingredients
Sucrose for Pellets.
Lactose for Tablets.
Storage
Store in a cool dark place
Questions Or Comments
www.Rxhomeo.com | 1.888.2796642 | [email protected]
Rxhomeo, Inc 1504 Fairway Dr. Ste W 100 Lewisville, TX 75057 USA
Package Label.Principal Display Panel
Image Description (Combo 33)
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