FDA Label for Quit Smoking Symptom Relief
View Indications, Usage & Precautions
Quit Smoking Symptom Relief Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
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.
Otc - Purpose
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
Indications & Usage
temporarily relieves symptoms associated with nicotine withdrawal such as:
- nausea
- irritability
- digestive upset
Otc - Stop Use
Stop use and ask doctor if symptoms for more than 3 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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.
Dosage & Administration
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.
Inactive Ingredient
lactose, sucrose
Otc - Questions
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073
Other
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.