Label: SINUSCALM ALLERGY- atropa belladonna, sanguinaria canadensis root, tablet
- NDC Code(s): 0220-9339-04
- Packager: Boiron
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated January 18, 2023
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
Active ingredients** (in each tablet)
Belladonna 3C HPUS (0.83 mg) (contains less than 10 -8 mg atropine alkaloids)
Sanguinaria canadensis 3C HPUS (0.83 mg) (contains less than 10 -7 mg chelidonine alkaloids)
Spigelia anthelmia 3C HPUS (0.83mg)
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
Sinus Relief*
Sinus Pressure Headache Congestion & Pain*
do not use if glued carton flaps are open or if the blister seal is broken
store below 86° F (30° C)
No Known Drug Interactions
Non-Drowsy
60 MELTAWAY TABLETS
Unflavored
No Phenylephrine
No Artificial Colors
No Artificial Flavors
No Artificial Sweeteners
No Rebound Congestion
Gluten-free
*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. - QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SINUSCALM ALLERGY
atropa belladonna, sanguinaria canadensis root, tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9339 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA 3 [hp_C] SPIGELIA ANTHELMIA (UNII: WYT05213GE) (SPIGELIA ANTHELMIA - UNII:WYT05213GE) SPIGELIA ANTHELMIA 3 [hp_C] SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 3 [hp_C] Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) MAGNESIUM STEARATE (UNII: 70097M6I30) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Boiron Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9339-04 1 in 1 BOX 07/28/2022 1 60 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/28/2022 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9339)
