Kali Sulph Tablet
FDA Label NDC 54973-5230

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hyland's Inc. for the product Kali Sulph (NDC 54973-5230). 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 directions, otc - purpose, formula, inactive ingredient, otc - do not use, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Directions

Adults & Children ages 6 - 12: 4 tablets. Children ages 2 - 6: 2 tablets. Dissolve under tongue 3 times a day. Use more frequently (every 15 minutes for up to 8 doses) with acute conditions.

Otc - Purpose

Relief of symptoms of the common cold. Relief of symptoms of pimples and blemishes associated with common acne.

Otc - Do Not Use

Do not use if imprinted cap band is broken or missing.

Otc - Ask Doctor

If symptoms persist for more than seven days or worsen, contact a licensed health care provider.

Otc - Stop Use

Discontinue use if symptoms are accompanied by a high fever (over 101° F).

Otc - Pregnancy Or Breast Feeding

If you are pregnant or nursing, seek the advice of a licensed health care provider before using this product.

Otc - Keep Out Of Reach Of Children

Keep this and all medications out of the reach of children.

Questions?

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