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): 54973-3257-1, 54973-3257-2, 54973-3257-3
  • 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.

Drug Label Information

Updated December 5, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • 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
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  • Uses

    Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.

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  • Warnings

    As with any drug, ask a doctor before use if pregnant or breast-feeding. Consult a physician if symptoms persist for more than 7 days.

    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.

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  • Directions

    Adults & children 12 years and over: As a relaxant: swallow 1-2 tablets with water as needed three times daily. For occasional sleeplessness: 1-3 tablets 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 tablet with water as needed three times daily. For occasional sleeplessness: 1-2 tablets 1/2 to 1 hour before retiring.

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  • Inactive ingredients

    Lactose, Magnesium Stearate, Microcrystalline Cellulose, Starch (Corn and Tapioca).

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  • Questions or comments?

    (800) 624-9659

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  • PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

    NDC 54973-3257-1

    HOMEOPATHIC

    NON-HABIT

    FORMING

    Natural

    Relief

    SINCE 1903

    Hyland's

    Calms Forté ®

    Sleep Aid

    Relieves stress to help you sleep*

    Safe & Effective Relief of:

    Occasional Sleeplessness

    Restless Sleep

    Stress

    50 Tablets| Actual Size 259 mg

    Carton

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  • INGREDIENTS AND APPEARANCE
    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
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3257
    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 ROUND Size 9mm
    Flavor Imprint Code HYL;CF
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54973-3257-1 1 in 1 CARTON 04/29/2016
    1 50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:54973-3257-2 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/29/2016
    3 NDC:54973-3257-3 4 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 04/29/2016
    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(54973-3257) , pack(54973-3257)
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