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, 54973-3257-7
  • 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 December 7, 2022

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  • Drug Facts

    Active ingredientsPurpose
    "HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Avena Sativa 4X HPUSstress, nervousness
    Calcarea Phosphorica 3X HPUSrestlessness
    Chamomilla 4X HPUSnervous irritability
    Ferrum Phosphoricum 3X HPUSnervousness
    Humulus Lupulus 4X HPUSoccasional sleeplessness
    Kali Phosphoricum 3X HPUSirritability
    Magnesia Phosphorica 3X HPUSmental anxiousness
    Natrum Phosphoricum 3X HPUSanxiousness
    Passiflora 4X HPUSrestless sleep from exhaustion
  • Uses

    ■ Temporarily relieves symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability

  • Warnings

    Stop use and ask a doctor if

    Symptoms persist more than 7 days or worsen.

    If pregnant or breastfeeding

    Ask a health professional before use.

    Keep out of reach of children

  • Directions

    ■ Use as directed.

    Adults and children
    12 years and over     		As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness:
    1-3 tablets before bedtime.
    Children 6 years
    to under 12 years     		As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness:
    1-2 tablets before bedtime.

  • Inactive ingredients

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

  • Questions?

    www.hylands.com or (800) 624-9659

  • *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

  • DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

  • PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON

    Hyland's

    NATURALS™

    CALMS

    FORTE®

    SLEEP AID*

    Sleeplessness

    Restless Sleep

    Stress

    Non-Habit

    Forming

    50

    TABLETS

    HOMEOPATHIC

    Carton

  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3257
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP4 [hp_X]
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_X]
    FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS4 [hp_X]
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
    MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3 [hp_X]
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER4 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code HYL;CF
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3257-11 in 1 CARTON04/29/2016
    150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:54973-3257-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2016
    3NDC:54973-3257-34 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2016
    4NDC:54973-3257-71 in 1 CARTON04/29/2016
    4100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/29/2016
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-3257) , pack(54973-3257) , label(54973-3257)
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