Active Ingredient
GRAPHITES HPUS 1X and higher
KALI MURIATICUM HPUS 1X and higher
Rxhomeo Homeopathic Combo-41
FDA Label NDC 15631-2491
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-41 (NDC 15631-2491). 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 Graphites and Kali Muriaticum for the treatment of symptoms associated with tinnitus or noises in ear.
Graphites;Uses: Graphites has marked action in treating ear disorders like tinnitus or noises in ear. The patient hears better when in a noise, when riding in a carriage or when there is rumbling sound. Loss of hearing with dryness of ears. Cracking, humming and roaring in ears. There is swelling of the glands under the ear. Hissing sounds in ear.
Kali Muriaticum;Uses: Kali Muriaticum is a chief head remedy for noises in the ear. Noises such as moving of train, sounds of birds. Snapping and cracking noise while swallowing or blowing nose. Kali Muriaticum also helps in chronic catarrhal conditions of the middle ear with noises in the ear. There is deafness from swelling of external ear and throat troubles. There is great effusion about the auricle. It also helps in glandular swellings and in infectious diseases of children. Glands about the ear are swollen. Kali Muriaticum also helps in deafness due to blow.
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.
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.
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 41)
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