Label: ARNICA- arnica montana tablet, soluble
- NDC Code(s): 54973-3084-1, 54973-3084-3
- Packager: Hyland's
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active ingredients
Arnica Montana 30X HPUS
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.Close
bruising, swelling, stiffness, muscle soreness and painClose
Temporarily relieves bruising, swelling, stiffness, and muscle soreness due to injuries or overexertion.Close
As with any drug, ask a doctor before use if pregnant or nursing. Consult a physician if symptoms persist for more than 7 days or worsen.
Keep this and all medications out of the reach of children. In case of accidental overdose, contact a medical professional or poison control center immediately.
In case of emergency, contact a medical professional or poison control center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.
Adults and children 12 years and over dissolve 1-2 tablets under tongue 4 times per day; 1-2 tablets may be taken in anticipation of strenuous activity or injury Children ages 6-12 years dissolve 1 tablet under tongue 4 times per day; 1 tablet may be taken in anticipation of strenuous activity or injury.
- Inactive ingredients
Acacia Gum, Lactose N.F.Close
- PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton
PAIN RELIEF FORMULA
50 Quick-Dissolving Tablets
MADE IN USA
- INGREDIENTS AND APPEARANCE
arnica montana tablet, soluble
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3084 Route of Administration ORAL DEA Schedule 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 2 NDC:54973-3084-3 4 in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 12/17/2008 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 MANUFACTURE(54973-3084) Establishment Name Address ID/FEI Business Operations MERICAL, INC. 029644978 MANUFACTURE(54973-3084)