Label: ARNICA- arnica montana tablet, soluble
- NDC Code(s): 54973-3084-1, 54973-3084-3, 54973-3084-5
- Packager: Hyland's Inc.
- Category: HUMAN OTC DRUG LABEL
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 April 24, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- "HPUS" is the Homeopathic Pharmacopœia of the United States.
- Uses
- Warnings
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
Directions
■ Use as directed.
Adults and children
12 years and overAt onset of symptoms, dissolve 1-2 tablets under tongue
every 4 hours as needed. If the initial dosage is not providing
immediate relief, dissolve 1 tablet under tongue every
15 minutes until relieved, up to 6 doses.
Children 6 years
to under 12 yearsAt onset of symptoms, dissolve 1 tablet under tongue
every 4 hours as needed. If the initial dosage is not providing
immediate relief, dissolve 1 tablet under tongue every
15 minutes until relieved, up to 6 doses. - Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- OTHER SAFETY INFORMATION
- PURPOSE
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ARNICA
arnica montana tablet, solubleProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3084 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) ACACIA (UNII: 5C5403N26O) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3084-1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2008 2 NDC:54973-3084-3 4 in 1 PACKET; Type 0: Not a Combination Product 12/17/2008 3 NDC:54973-3084-5 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/17/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 12/17/2008 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations Hyland's Inc. 008316655 manufacture(54973-3084) , pack(54973-3084) , label(54973-3084)