Zicam Ultra Cold Remedy Rapidmelts Tablet
FDA Label NDC 10237-476

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Church & Dwight Co., Inc. for the product Zicam Ultra Cold Remedy Rapidmelts (NDC 10237-476). 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, warnings, 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

→ Active Ingredients (in Each Tablet)

→ Purpose

→ Uses

→ Warnings

→ Otc - Stop Use

→ Otc - Pregnancy Or Breast Feeding

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions? Comments?

→ Principal Display Panel - 18 Tablet Bottle Carton

Other

Drug Facts

DISTRIBUTED BY CHURCH & DWIGHT CO., INC.
EWING, NJ 08628

Active Ingredients (In Each Tablet)

Zincum aceticum 2x
Zincum gluconicum 1x

Purpose

Reduces duration of the common cold and helps relieve nasal congestion

Uses

Reduces duration of the common cold and helps relieve nasal congestion

Zicam® ULTRA Cold Remedy was not formulated to be effective for flu or allergies.

Warnings

If you are allergic or sensitive to zinc, consult a doctor before using.

Otc - Stop Use

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

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 2 – 3 hours, not to exceed 7 tablets in 24 hours. Take until symptoms are gone.
- 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