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

CALMS NERVE TENSION SLEEPLESSNESS by

Drug Labeling and Warnings

CALMS NERVE TENSION SLEEPLESSNESS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-1120
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	1 [hp_X]
AVENA SATIVA LEAF (UNII: 206PI19V7R) (AVENA SATIVA LEAF - UNII:206PI19V7R)	AVENA SATIVA LEAF	1 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83)	HOPS	1 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
LACTOSE (UNII: J2B2A4N98G)
STARCH, TAPIOCA (UNII: 24SC3U704I)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STARCH, CORN (UNII: O8232NY3SJ)

Product Characteristics
Color	brown (TAN)	Score	no score
Shape	ROUND	Size	9mm
Flavor		Imprint Code	HYL;CM
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-1120-3	1 in 1 CARTON	01/01/1980
1		100 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		01/01/1980

Labeler - Hyland's (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-1120)