Label: APETITE RELIEF- avena sativa, berberis vulgaris, calcarea carbonica, capsicum annuum, carbo vegetabilis, fucus vesiculosus, nux vomica, thyroidinum lozenge
- NDC Code(s): 17312-056-14
- Packager: TRP Company
- 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 10, 2023
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- INACTIVE INGREDIENT
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INDICATIONS & USAGE
According to homeopathic indications, these ingredients temporarily relieve and calm appetite related symptoms of: • excessive appetite • insatiable hunger • overeating • food cravings • empty stomach feeling • irritability after diagnosis by a physician. *These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
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DOSAGE & ADMINISTRATION
• Suitable for adults and children 12 years and above. • To use a lozenge, place it in your mouth and let it dissolve slowly. Try not to chew or swallow the lozenge. • Use one lozenge 10 to 15 minutes before each meal. If you feel hungry between meals, you may take one lozenge as needed, up to 10 lozenges a day or as directed by your physician. • This product’s effectiveness is directly related to the degree which you reduce your daily food intake. Attempts at weight reduction without a change in personal habits to support weight loss will compromise this product’s effectiveness. • Excess consumption may have a laxative effect.
• Homeopathic remedies may not be effective for everyone. -
WARNINGS
USE ONLY AFTER DIAGNOSIS BY A PHYSICIAN AND UNDER THE SUPERVISION OF A PHYSICIAN.
• This product is intended to complement not replace standard medical treatments.•Initial worsening of symptoms may occur.
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OTHER SAFETY INFORMATION
• There are no known contraindications. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects. • Store in a cool dark location. • Appetite ReliefTM Homeopathic Lozenges are a homeopathic dilution.
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PURPOSE
Active Ingredients Purpose
Avena sativa HPUS 3x, 6x.............Cleansing, Detoxing
Berberis vulgaris HPUS 6x, 12x.....Excessive appetite, Insatiable hunger, Overeating
Calcarea carbonica HPUS 6x,18x...Tendency to gain weight
Capsicum annuum HPUS 6x..........Food cravings, Metabolism support
Carbo vegetabilis HPUS 6x,12x.......Craving carbs,sweets and starches
Fucus vesiculosus HPUS 6x.............Empty stomach feeling, Digestion support
Nux vomica HPUS 6x, 12x, 18x......Irritability, Impatience, Oversensitivity
Thyroidinum HPUS 18x...................Maintain balance in the appetite center of the brain - ACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
APETITE RELIEF
avena sativa, berberis vulgaris, calcarea carbonica, capsicum annuum, carbo vegetabilis, fucus vesiculosus, nux vomica, thyroidinum lozengeProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:17312-056 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP 9 [hp_X] BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U) BERBERIS VULGARIS ROOT BARK 12 [hp_X] CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED 18 [hp_X] FUCUS VESICULOSUS (UNII: 535G2ABX9M) (FUCUS VESICULOSUS - UNII:535G2ABX9M) FUCUS VESICULOSUS 6 [hp_X] OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I) OYSTER SHELL CALCIUM CARBONATE, CRUDE 6 [hp_X] ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 6 [hp_X] STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 18 [hp_X] Inactive Ingredients Ingredient Name Strength SORBITOL (UNII: 506T60A25R) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) LACTOSE (UNII: J2B2A4N98G) SUCRALOSE (UNII: 96K6UQ3ZD4) ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CALCIUM STEARATE (UNII: 776XM7047L) SPIRULINA MAXIMA (UNII: 9K7IG15M0Q) RIBOFLAVIN (UNII: TLM2976OFR) XYLITOL (UNII: VCQ006KQ1E) SPEARMINT (UNII: J7I2T6IV1N) PEPPERMINT (UNII: V95R5KMY2B) Product Characteristics Color white Score score with uneven pieces Shape OVAL ((Lozenge)) Size 10mm Flavor MINT Imprint Code TRP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17312-056-14 1 in 1 CARTON 03/01/2016 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 03/01/2016 Labeler - TRP Company (105185719)