Label: HARPAGOPHYTUM- harpagophytum procumbens root pellet
- NDC Code(s): 0220-2374-41, 0220-2374-43
- 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 December 21, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
Tube - Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Box - Adults and children 12 years of age and older: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved, or as directed by a doctor. If pain increases, take every 2 hours, up to 8 times a day.
Children under 12 years of age: Ask a doctor
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SPL UNCLASSIFIED SECTION
Tube - Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
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.Box - do not use if glued carton end flaps are open or if the 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
Meltaway pellets
16 DOSES PER TUBE
3 TUBES
Approx. 80 pellets each
Total 240 pellets
Arthritis Pain Relief*
Pain Stiffness Discomfort*
*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. - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
HARPAGOPHYTUM
harpagophytum procumbens root pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-2374 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) (HARPAGOPHYTUM PROCUMBENS ROOT - UNII:1OYM338E89) HARPAGOPHYTUM PROCUMBENS ROOT 6 [hp_C] in 6 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) Product Characteristics Color white Score Shape ROUND Size 4mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-2374-41 6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product 01/22/2021 2 NDC:0220-2374-43 3 in 1 BOX 03/22/2022 2 6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/22/2021 Labeler - Boiron (282560473) Registrant - Boiron, Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-2374)
