Nicotinum
FDA Label NDC 57520-0615

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Apotheca Company for the product Nicotinum (NDC 57520-0615). 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 - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, otc - keep out of reach of children, indications & usage, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENT:  Nicotinum 6X.

Otc - Purpose

INDICATIONS:  To assist with withdrawal symptoms associated with nicotine.

Warnings

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

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

Do not use if tamper evident seal is broken or missing.  Store in a cool, dry place.


Dosage & Administration

DIRECTIONS:  Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional.  If symptoms persist, consult a health care professional.  Consult a physician for use in children under 12 years of age.

Inactive Ingredient

INACTIVE INGREDIENTS:  Demineralized water,  25% Ethanol.


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.


Indications & Usage

INDICATIONS:  To assist with withdrawal symptoms associated with nicotine.

Otc - Questions

Dist. By:

Prime Time Int'l Company

2019 West Lone Cactus Dr.

Phoenix, AZ 85027


Package Label.Principal Display Panel

NICOTINUM 6X

HOMEOPATHIC

2 FL OZ (30 ml)

Nicotinum 6x (Mm1)

Nicotinum 6x (Mm1)


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