Label: CALMS NERVE TENSION SLEEPLESSNESS- passiflora incarnata flower, avena sativa leaf, hops, and chamomile tablet

  • 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 7, 2022

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

View All Sections
  • INDICATIONS & USAGE

    Temporary symptomatic treatment for relief of simple nervous tension & occasional sleeplessness.

  • HOMEOPATHIC FORMULA

    PASSIFLORA 1X Triple Strength HPUS (Passion Flower)

    AVENA SATIVA 1X Double Strength HPUS (Oat)

    HUMULUS LUPULUS 1X Double Strength HPUS (Hops)

    CHAMOMILLA 2X HPUS (Chamomile)

    “HPUS” indicates the active

    ingredients are in the official

    Homeopathic Pharmacopoeia

    of the United States.

    Lactose N.F.,

    Starch (Corn and Tapioca),

    Vegetable Magnesium Stearate.

  • WARNING

    Do not use if imprinted cap band is missing or broken.

    If symptoms persist for more than seven days or worsen, consult a Health Care Professional.

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults & Children 12 and over:

    As a relaxant: Swallow 1-2 tablets with water as needed 3 times daily. For occasional sleeplessness:

    1-3 tablets 1/2 to 1 hour before retiring.

    Children 6-12 years:

    As a relaxant: 1 tablet with water as needed 3 times daily. For occasional sleeplessness: 1-2 tablets 1 hour before retiring.

  • QUESTIONS?

    CALL US:

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

    NDC 54973-1120-3

    Hyland's®

    Calms

    Simple Nerve Tension
    & Occasional Sleeplessness*

    Temporary symptomatic

    treatment for relief of simple

    nervous tension & occasional

    sleeplessness.

    NON-HABIT FORMING

    100 4 g TABLETS

    1

  • INGREDIENTS AND APPEARANCE
    CALMS NERVE TENSION SLEEPLESSNESS 
    passiflora incarnata flower, avena sativa leaf, hops, and chamomile tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-1120
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER1 [hp_X]
    AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R) AVENA SATIVA LEAF1 [hp_X]
    HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS1 [hp_X]
    CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    STARCH, TAPIOCA (UNII: 24SC3U704I)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorbrown (TAN) Scoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code HYL;CM
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-1120-31 in 1 CARTON01/01/1980
    1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/1980
    Labeler - Hyland's Inc. (008316655)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hyland's Inc.008316655manufacture(54973-1120) , pack(54973-1120) , label(54973-1120)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!