The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Histaminum 30c Allergy Relief (NDC 0220-2488). 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, warnings, otc - do not use, otc - ask doctor, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredient** (in each pellet)
Histaminum Hydrochloricum 30C HPUS (0.443 mg)
The letters "HPUS" indicate that the component in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Purpose*
Histaminum hydrochloricum 30C HPUS (0.443 mg) ... Relieves allergies
Uses*
Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:
Do not use to prevent hives.
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Directions Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue every 15 minutes for 1 hour. Then, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Inactive ingredients lactose, sucrose.
Questions, Comments?
www.BoironUSA.com
[email protected]
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
Newtown Square, PA 19073-3267
Other information do not use if glued carton end flaps are open or if pellet dispenser seal is broken
3 Tubes
Approx. 80 pellets each
Total 240 pellets
16 Doses per tube
Turn tube upside down Twist until 5 pellets are dispensed Remove cap and pour pellets under the tongue
Meltaway pellets
Allergy relief*
On the go allergy relief*
Non-drowsy
Hay Fever Hives Indoor & Outdoor Allergies*
1 Tube
Do not use if pellet dispenser seal is broken.
Contains approx. 80 quick dissolving pellets per tube.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*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.
Label (Hishyd30c)
Box (Box)
* Please review the disclaimer below.
