NativeRemedies® QuitCalm™ Oral Spray

Manufacturer
Silver Star Brands | King Bio
Effective date
2016-12-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:21:01

Label at a glance#

ProductQuitCalm
Active ingredientSTRYCHNOS NUX-VOMICA SEED, DELPHINIUM STAPHISAGRIA SEED, MATRICARIA RECUTITA, ARSENIC TRIIODIDE, BROMINE
Label structure10 sections

Indications and uses

Assists with occasional moodiness and agitation associated with nicotine withdrawal. Nicotine free. *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Dosage and administration

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use up to 10 times daily for the first 10 days and as needed thereafter. Adults: Take 3 pump sprays.

Label contents#

Full prescribing information#

HPUS Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Equal volumes of each ingredient: Arsenicum iodatum 30C, Bromium 6C, Chamomilla 30C, Nux vomica 6C, Staphysagria 30C.

Uses*:

INDICATIONS & USAGE SECTION

Assists with occasional moodiness and agitation associated with nicotine withdrawal. Nicotine free.

*This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

Warnings:

WARNINGS SECTION

If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use up to 10 times daily for the first 10 days and as needed thereafter. Adults: Take 3 pump sprays.

OTHER SAFETY INFORMATION

All Native Remedies health products are especially formulated by experts in the field of natural health and are manufactured according to the highest pharmaceutical standards for maximum safety and effectiveness. For more information, visit us at www.nativeremedies.com.

Contains no artificial flavors or colorants. No gluten added.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Citric acid, potassium sorbate, purified water.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - PURPOSE SECTION

Assists with occasional moodiness & agitation associated with nicotine withdrawal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

QuitCalm LabelQuitCalm Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68703-274-022020-02-11C16284748780-19d75b9d0-f4b4-f424-e053-dadaa90a57ceNativeRemedies® QuitCalm™ Oral Spray
68703-274-022020-01-31C16284748780-19d75b9d0-f4b4-f424-e053-dadaa90a57ceNativeRemedies® QuitCalm™ Oral Spray

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68703-27468703-274-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
439023f1-5a86-3160-e054-00144ff88e88439023f1-5a85-3160-e054-00144ff88e882016-12-13WarningsExact identifier
spl id: 439023f1-5a86-3160-e054-00144ff88e88
spl set id: 439023f1-5a85-3160-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.