Label: CALMS FORTE- avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower tablet
- NDC Code(s): 54973-3274-1
- Packager: Hyland's
- 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.
Updated December 5, 2017
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
Active ingredients Purpose "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States. Avena Sativa 4X HPUS stress, nervousness Calcarea Phosphorica 3X HPUS restlessness Chamomilla 4X HPUS nervous irritability Ferrum Phosphoricum 3X HPUS nervousness Humulus Lupulus 4X HPUS occasional sleeplessness Kali Phosphoricum 3X HPUS irritability Magnesia Phosphorica 3X HPUS mental anxiousness Natrum Phosphoricum 3X HPUS anxiousness Passiflora 4X HPUS restless sleep from exhaustion
Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.Close
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.
Do not use if imprinted tamper band is broken or missing.
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 & children 12 years and over: As a relaxant: swallow 1-2 caplets with water as needed three times daily. For occasional sleeplessness: 1-3 caplets 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 caplet with water as needed three times daily. For occasional sleeplessness: 1-2 caplets 1/2 to 1 hour before retiring.Close
- Inactive ingredients
Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).Close
- Questions or comments?
- PRINCIPAL DISPLAY PANEL - 32 Caplet Bottle Carton
Calms Forté ®
Relieves stress to help you sleep*
Safe & Effective Relief of:
32 Caplets| Actual Size 356 mg
- INGREDIENTS AND APPEARANCE
avena sativa flowering top, tribasic calcium phosphate, matricaria recutita, ferrosoferric phosphate, hops, potassium phosphate, dibasic, magnesium phosphate, dibasic trihydrate, sodium phosphate, dibasic, heptahydrate, and passiflora incarnata flower tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3274 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 4 [hp_X] TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE 3 [hp_X] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 4 [hp_X] FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE 3 [hp_X] HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS 4 [hp_X] POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC 3 [hp_X] MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 3 [hp_X] SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE 3 [hp_X] PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER 4 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G) MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) STARCH, TAPIOCA (UNII: 24SC3U704I) Product Characteristics Color white Score no score Shape OVAL Size 14mm Flavor Imprint Code HYL;CF Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3274-1 1 in 1 CARTON 04/29/2016 1 32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/29/2016 Labeler - Hyland's (028570695) Establishment Name Address ID/FEI Business Operations Standard Homeopathic Company 008316655 manufacture(54973-3274) , pack(54973-3274)