The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Quit Smoking Symptom Relief (NDC 0220-9318). 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, indications & usage, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients** (in each pellet)
Lobelia inflata 6C HPUS (0.44 mg) (contains less than 10 -12 mg lobeline alkaloids per pellet)
Nux vomica 30C HPUS (0.44 mg) (contains less than 10- 12 mg strychnine alkaloids per pellet)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Lobelia inflata 6C HPUS (0.44 mg) ... Relieves nausea associated with nicotine withdrawal
Nux vomica 30C HPUS (0.44 mg) ... Relieves irritability and digestive upset associated with nicotine withdrawal
temporarily relieves symptoms associated with nicotine withdrawal such as:
Stop use and ask doctor if symptoms for more than 3 days or worsen.
If pregnant or breastfeeding, 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.
Directions Retain this carton for full directions.
Adults 21 years of age and older:
Nausea: At the onset of symptoms, dissolve 5 pellets of Lobelia inflata 6C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Irritability or Digestive Upset: At the onset of symptoms, dissolve 5 pellets of Nux vomica 30C under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
lactose, sucrose
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
do not use if glued end flaps are open or if pellet dispenser seal is broken
contains 0.25 g of sugar per dose
Turn tube upside down
Twist until 5 pellets are dispensed
Remove cap and pour pellets under the tongue
3 Tubes
Approx. 80 pellets each
Total 240 pellets
Meltaway pellets
Nausea Irritability Digestive Upset*
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
* Please review the disclaimer below.
