CALMS NERVE TENSION SLEEPLESSNESS

Manufacturer: Hyland's Inc.
Effective date: 2022-12-07
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-01 21:45:16

Label at a glance#

ProductCALMS NERVE TENSION SLEEPLESSNESS

Active ingredientPASSIFLORA INCARNATA FLOWER, AVENA SATIVA LEAF, HOPS, CHAMOMILE

Label structure6 sections

Dosage and administration

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

Contacts and useful links#

PhoneLabel contact(800) 624-9659

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

OTC - PURPOSE SECTION

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

HOMEOPATHIC FORMULA

OTC - ACTIVE INGREDIENT SECTION

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.

INACTIVE INGREDIENT SECTION

Lactose N.F.,

Starch (Corn and Tapioca),

Vegetable Magnesium Stearate.

WARNING

WARNINGS SECTION

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of reach of children.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults & Children 12 and over:

SPL UNCLASSIFIED SECTION

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:

SPL UNCLASSIFIED SECTION

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

QUESTIONS?

OTC - QUESTIONS SECTION

CALL US:

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVENA SATIVA LEAF	ACTIVE INGREDIENT	206PI19V7R	1
CHAMOMILE	ACTIVE INGREDIENT	FGL3685T2X	1
HOPS	ACTIVE INGREDIENT	01G73H6H83	1
PASSIFLORA INCARNATA FLOWER	ACTIVE INGREDIENT	K8F3G29S6Z	1
AVENA SATIVA LEAF	ACTIVE MOIETY	206PI19V7R	1
CHAMOMILE	ACTIVE MOIETY	FGL3685T2X	1
HOPS	ACTIVE MOIETY	01G73H6H83	1
PASSIFLORA INCARNATA FLOWER	ACTIVE MOIETY	K8F3G29S6Z	1
LACTOSE	INACTIVE INGREDIENT	J2B2A4N98G	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	1
STARCH, TAPIOCA	INACTIVE INGREDIENT	24SC3U704I	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

CALMS NERVE TENSION SLEEPLESSNESS
passiflora incarnata flower, avena sativa leaf, hops, and chamomile
LACTOSE
STARCH, TAPIOCA
MAGNESIUM STEARATE
STARCH, CORN
PASSIFLORA INCARNATA FLOWER
AVENA SATIVA LEAF
HOPS
CHAMOMILE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-1120	54973-1120-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LACTOSE	J2B2A4N98G	IACT
STARCH, TAPIOCA	24SC3U704I	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
STARCH, CORN	O8232NY3SJ	IACT
PASSIFLORA INCARNATA FLOWER	K8F3G29S6Z	ACTIB
AVENA SATIVA LEAF	206PI19V7R	ACTIB
HOPS	01G73H6H83	ACTIB
CHAMOMILE	FGL3685T2X	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 99 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	CAPSULE / ORAL	100 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		21 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TROCHE / ORAL		315 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION / ORAL		900 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, EXTENDED RELEASE / ORAL		184 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, EXTENDED RELEASE / ORAL		194 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / RESPIRATORY (INHALATION)	90 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED / ORAL	590 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	PELLET / ORAL		24 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CREAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	GRANULE, FOR SUSPENSION / ORAL	512.5 mg/5ml		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET / ORAL		980 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	SUSPENSION/ DROPS / ORAL		90 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, FILM COATED / ORAL		2000 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	INSERT / VAGINAL		147 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	DROPS / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	CAPSULE, DELAYED RELEASE / ORAL		216 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	INJECTION / INTRAVENOUS	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / ORAL		1116 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	SYSTEM / INTRAVITREAL	0.02 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET / BUCCAL	16.6 mg		Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, ORALLY DISINTEGRATING / ORAL		100 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	TABLET, COATED / ORAL		256 mg	Exact identifier — unii candidate 22 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, TAPIOCA	STARCH, TAPIOCA	24SC3U704I	TABLET / ORAL	5 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
STARCH, CORN	STARCH, CORN	O8232NY3SJ	PASTILLE / ORAL	NA		Exact identifier — unii candidate 22 equally ranked IID candidates
LACTOSE	LACTOSE	J2B2A4N98G	TABLET, DELAYED RELEASE / ORAL		160 mg	Exact identifier — unii candidate 36 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
32d9c85c-7dc3-d7e7-e063-6394a90ac823			44de26de-e362-4330-adac-a22fb482e0f4	2025-04-15	Warnings	Exact identifier spl set id: 44de26de-e362-4330-adac-a22fb482e0f4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.