The following Structured Product Label (SPL) was submitted to the FDA by Medinatura Inc for the product Hendel Periodontal And Tooth Pain Relief (NDC 62795-1133). 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 warnings, purpose, keep out of reach of children, uses, active ingredients, inactive ingredients, directions, hendel periodontal and tooth pain relief, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Stop use and ask doctor if symptoms do not improve in 7 days or if swelling or fever develops or if irritation, pain or redness persist or worsens.
Do not use if sensitivity to Periodontal & Tooth Pain Relief or any of its ingredients exists. In case of accidental overdose, contact a Poison Control Center immediately.
Periodontal & Tooth Pain Relief
KEEP OUT OF REACH OF CHILDREN
For the temporary relief of:
• Sore gums
• Toothache
• Bad breath
Active Ingredients:
Each tablet contains equal parts of Borax 8X; Calcarea phosphorica 12X; Mercurius solubilis 12X; Silicea 12X
Inactive Ingredients:
Lactose, Magnesium stearate
Dosage: Adults 18 and over: 1 tablet sublingually or dissolved completely in mouth 2 to 3 times per day or as directed by a physician.
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