Active Ingredient
HELLEBORUS NIGER HPUS 3X and higher
KALI PHOSPHORICUM HPUS 1X and higher
Rxhomeo Homeopathic Combo 13
FDA Label NDC 15631-2463
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 13 (NDC 15631-2463). 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 Helleborus Niger and Kali Phosphoricum for relief of symptoms associated with depression.
Helleborus Niger: Helleborus Niger is a chief remedy for treating depression. The patient is very much irritable and easily angered. He does not want to be disturbed. The patient is very much melancholic, woeful, despairing, silent or extremely anguished. It is especially suitable to girls at puberty or when menses fail to return after appearing. The patient is worse from consolation. Helleborus Niger is also suitable for many brain troubles during dentition with threatned effusion. Also unconscious and stupid when questioned and answers slowly. Helleborus Niger also helps in homesickness.
Kali Phos: Kali Pho is a suitable remedy depression. The patient is very nervous, depressed and general irritability. There is great despondency about business and loss of memory. Indisposition to meet people. The patient is shy with no inclination to converse. Want of energy, slightest labour seems heavy task. Also brain fag from over work. Anxiety and nervousness. Gloomy and always looks at the dark side of everything. There is extreme lassitude and depression. There are hallucinations and illusions of senses. Also helps in anemic conditions.
Indications
Condition listed above or as directed by the physician
Dosage
Adults: Take 4-5 pellets or tablets orally by mouth and allow them to dissolve on tongue. Repeat at least 3 times a day, about 30 minutes before or after food. Similarly take the second remedy after a gap of 30 minutes, make sure to remember the sequence.
Children: Half of 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 13)
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