CALMS NERVE TENSION SLEEPLESSNESS- passiflora incarnata flower, avena sativa leaf, hops, and chamomile tablet 
Hyland's Inc.

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.

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CALMS NERVE TENSION SLEEPLESSNESS

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

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)

Revised: 12/2022
Document Id: ef43098f-998a-7001-e053-2995a90aa820
Set id: 44de26de-e362-4330-adac-a22fb482e0f4
Version: 3
Effective Time: 20221207
 
Hyland's Inc.