Zicam ®

Zicam ®
SPL v4
SPL
SPL Set ID c8091b9d-f240-e479-e053-2a95a90a037a
Route
ORAL
Published
Effective Date 2021-08-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (2 [hp_X]) Sambucus Nigra Flowering Top (4 [hp_X])
Inactive Ingredients
Citric Acid Acetate Corn Syrup Water Lecithin, Soybean Fd&c Blue No. 1 Aluminum Lake Sucralose Fd&c Red No. 40 Methyl Salicylate Glycerin Malic Acid Sucrose

Identifiers & Packaging

Pill Appearance
Imprint: Z Shape: round Color: purple Size: 15 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2021-08-02

Description

Zincum aceticum 2x Zincum gluconicum 2x Sambucus nigra (elderberry) 4x

Purpose

Active ingredients (in each tablet) Purpose Zincum aceticum 2x Zincum gluconicum 2x Reduces duration of the common cold and helps relieve nasal congestion Sambucus nigra (elderberry) 4x Helps relieve cold symptoms Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Purpose
Active ingredients (in each tablet) Purpose
Zincum aceticum 2x







Zincum gluconicum 2x
Reduces duration of the common cold and helps relieve nasal congestion
Sambucus nigra (elderberry) 4x Helps relieve cold symptoms
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Description

Zincum aceticum 2x Zincum gluconicum 2x Sambucus nigra (elderberry) 4x

Uses

Reduces duration of the common cold and helps relieve nasal congestion

------------------------------------------------------------------------------------------------------

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

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

Section 50569-3

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

Section 53414-9

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

Warnings

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.

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. Completely dissolve lozenge in mouth. Do not chew. Do now 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
Other Information
  • store between 15-29°C (59-84°F)
  • avoid freezing and excessive heat
Inactive Ingredients

citric acid, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, malic acid, purified water, soy lecithin, sucralose, sucrose

Questions? Comments?

call 877-942-2626 toll free



www.zicam.com

Active Ingredients (in Each Lozenge)

Zincum aceticum 2x

Zincum gluconicum 2x

Sambucus nigra (elderberry) 4x

Principal Display Panel 25 Individually Wrapped Center Filled Lozenges

NEW!

Plus ELDERBERRY

ZICAM®

COLD REMEDY

PRE-COLD®

FIGHTER

ZINC &

ELDERBERRY

LOZENGE

Elderberry Flavor

HOMEOPATHIC

TAKE AT

THE FIRST SIGN

25 INDIVIDUALLY WRAPPED

CENTER FILLED

LOZENGES


Structured Label Content

Uses

Reduces duration of the common cold and helps relieve nasal congestion

------------------------------------------------------------------------------------------------------

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

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms, including cough, persist, recur or are accompanied by a fever, rash, or persistent headache, or if new symptoms occur. A persistent cough that lasts for more than one week may be a sign of a serious condition.

Section 50569-3 (50569-3)

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

Section 53414-9 (53414-9)

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

Purpose
Active ingredients (in each tablet) Purpose
Zincum aceticum 2x







Zincum gluconicum 2x
Reduces duration of the common cold and helps relieve nasal congestion
Sambucus nigra (elderberry) 4x Helps relieve cold symptoms
Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Warnings

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.

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. Completely dissolve lozenge in mouth. Do not chew. Do now 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
Other Information (Other information)
  • store between 15-29°C (59-84°F)
  • avoid freezing and excessive heat
Inactive Ingredients (Inactive ingredients)

citric acid, corn syrup, FD&C Blue No. 1, FD&C Red No. 40, flavor, glycerin, malic acid, purified water, soy lecithin, sucralose, sucrose

Questions? Comments?

call 877-942-2626 toll free



www.zicam.com

Active Ingredients (in Each Lozenge) (Active ingredients (in each lozenge))

Zincum aceticum 2x

Zincum gluconicum 2x

Sambucus nigra (elderberry) 4x

Principal Display Panel 25 Individually Wrapped Center Filled Lozenges (PRINCIPAL DISPLAY PANEL - 25 INDIVIDUALLY WRAPPED CENTER FILLED LOZENGES)

NEW!

Plus ELDERBERRY

ZICAM®

COLD REMEDY

PRE-COLD®

FIGHTER

ZINC &

ELDERBERRY

LOZENGE

Elderberry Flavor

HOMEOPATHIC

TAKE AT

THE FIRST SIGN

25 INDIVIDUALLY WRAPPED

CENTER FILLED

LOZENGES


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)