Ultra Cold Remedy Rapidmelts
FDA Label NDC 66007-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Izeen Pharma, Inc. for the product Ultra Cold Remedy Rapidmelts (NDC 66007-103). 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 other, active ingredients (in each tablet), purpose, uses, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Manufactured by Izeen Pharma, Inc. 6900 English Muffin Way, Unit A, Frederick, MD 21703

Active Ingredients (In Each Tablet)

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration and severity of the common cold

Uses

  • reduces duration of the common cold
  • reduces the severity of cold symptoms:
    • sore throat
    • stuffy nose
    • sneezing
    • coughing
    • nasal congestion

      • Zicam® ULTRA Cold Remedy was formulated to shorten the duration of the common cold and was not formulated to be effective for flu or allergies.

Ask A Doctor Before Use If You Have

  • a sensitivity to zinc or are allergic to zinc

Otc - Stop Use

Stop use and ask a doctor if symptoms persist or are accompanied by fever

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • for best results, use at the first sign of a cold and continue to use until symptoms completely subside
  • adults and children 12 years of age and older:
    • take 1 tablet at the onset of symptoms
    • dissolve entire tablet in mouth. Do not chew. Do not swallow whole.
    • repeat every 4-6 hours, not to exceed 4 tablets in 24 hours
    • to avoid minor stomach upset, do not take on an empty stomach
    • do not eat or drink for 15 minutes after use. Do not eat or drink citrus fruits or juices for 30 minutes before or after use. Otherwise, drink plenty of fluids.
    • children under 12 years of age: ask a doctor before use

Other Information

  • store between 15-29° (59-84°F)

Inactive Ingredients

artificial flavor, crospovidone, FD&C red no. 40 aluminum lake, magnesium stearate, mannitol, monoammonium glycyrrhizinate, sodium starch glycolate, stearic acid, sucralose

Questions/Comments

Questions/Comments call 1-844-287-0260

Principal Display Panel - 18 Tablet Carton

NDC# 66007-103-18

Principal Display Panel-carton (Ultrazinccherry)

Principal Display Panel-carton (Ultrazinccherry)

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