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|Product NDC Code||15631-0249|
|Labeler Name||Rxhomeo Private Limited d.b.a. Rxhomeo, Inc|
Active ingredientA list of the active, medicinal ingredients in the drug product.
ACTIVE INGREDIENT KALI CARBONICUM HPUS 2X and higher
Dosage and administrationInformation about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
DOSAGE 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.
Inactive ingredientA list of inactive, non-medicinal ingredients in a drug product.
INACTIVE INGREDIENTS Sucrose
Indications and usageA statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
INDICATIONS Condition listed above or as directed by the physician
PurposeInformation about the drug product’s indications for use.
USES USES: Temporary Relief - Chest Congestion, Low Back Pain* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Spl product data elementsUsually a list of ingredients in a drug product.
KALI CARBONICUM KALI CARBONICUM SUCROSE POTASSIUM CARBONATE CARBONATE ION
Package label principal display panelThe content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
Mini-Label Label-Pellets Blister-label carton-label
Do not useInformation about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use if capseal is broken or missing. Close the cap tightly after use.
Keep out of reach of childrenInformation pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep this and all medication out of reach of children
QuestionsA telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
QUESTIONS OR COMMENTS www.Rxhomeo.com | 1.888.2796642 | [email protected] Rxhomeo, Inc 3200 Commander Dr, Ste 100-W1, Carrollton, TX 75006 USA
Stop useInformation about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional
Pregnancy or breast feedingPregnancy or Breast feeding
As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product
Storage and handlingInformation about safe storage and handling of the drug product.
STORAGE Store in a cool dark place
WarningsInformation about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
WARNINGS This product is to be used for self-limiting conditions If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product Keep this and all medication out of reach of children Do not use if capseal is broken or missing. Close the cap tightly after use.
Disclaimer: Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API