Otc - Purpose
Cold Symptoms
Hemorrhoid
Chapped Skin
Calc Fluor 6x Tablet, Soluble
FDA Label NDC 54973-4087
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 Calc Fluor 6x (NDC 54973-4087). 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 otc - purpose, otc - active ingredient, uses, sore throat warning, ask a doctor before use if you have, stop use and ask a doctor if, if pregnant or breastfeeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
| Active ingredients | Purpose |
| Calcarea Fluorica 6X HPUS | cold symptoms, hemorrhoids, chapped and cracked skin |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses
■Temporarily relieves:
■ cold symptoms ■ chapped or cracked skin
■ itching or pain due to hemorrhoids
Sore Throat Warning
If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting,
consult a doctor promptly.
Ask A Doctor Before Use If You Have
■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).
Stop Use And Ask A Doctor If
■ bleeding occurs. ■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops.
■ cough tends to recur or is accompanied by a fever, rash or persistent headache.
If Pregnant Or Breastfeeding
Ask a health professional before use.
Directions
■ Use as directed.
■ Adults and children 6 years and over: Dissolve 1 tablet under tongue 3 times per day.
Inactive Ingredients
Acacia Gum, Lactose.
Questions?
www.hylands.com or [email protected]
Package Label - 100 Tablets Bottle Carton
Hyland's
NATURALS™
CELL SALT
#1
CALC FLOUR 6X
Cold Symptoms*
Hemorrhoids*
Chapped Skin*
100
QUICK - DISSOLVING
SINGLE TABLET DOSES
HOMEOPATHIC
Carton (Cafl6xt100 Carton)
* Please review the disclaimer below.
