Smoke-x
FDA Label NDC 61657-0915
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by White Manufacturing Inc. Dba Micro-west for the product Smoke-x (NDC 61657-0915). 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, otc - keep out of reach of children, indications & usage, warnings, directions, inactive ingredient, manufacture, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
RELIEVES CRAVING FOR TOBACCO SMOKE, CHEWING TOBACCO. HELPS WITH NERVOUSNESS, ANXIETY, IRRITABILITY WHEN QUITTING, COUGH, SHORTNESS OF BREATH, DIFFICULT BREATHING
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN
Indications & Usage
INDICATIONS: RELIEVES CRAVING FOR TOBACCO SMOKE, CHEWING TOBACCO. HELPS WITH NERVOUSNESS, ANXIETY, IRRITABILITY WHEN QUITTING, COUGH, SHORTNESS OF BREATH, DIFFICULT BREATHING
Warnings
WARNING: IF SYMPTOMS PERSIST OR WORSEN, SEEK A PHYSICIANS ADVICE. IF PREGNANT OR NURSING, TAKE ONLY ON ADVICE OF PHYSICIAN. USE ONLY IF TAMPER RESISTANT SEAL IS IN TACT
Directions
DIRECTIONS: FOR SELF-HEALING CONDITIONS, TAKE 2 PUMP SPRAYS 3 TIMES DAILY. HOLD UNDER TONGUE 30 SECONDS BEFORE SWALLOWING. MORE FREQUENT DOSAGES MAY BE USED ACCORDING TO SYMPTOMATIC NEEDS
Inactive Ingredient
POTASSIUM SORBATE AS STABILIZER
Manufacture
MANUFACTURED FOR MICRO-WEST
DOUGLAS, WY 82633
1-307-358-5066
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