FDA.reportPublic FDA data

CALMS FORTE

Manufacturer
Hyland's Inc.
Effective date
2022-12-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:18:49

Label at a glance#

ProductCALMS FORTE
Active ingredientAVENA SATIVA FLOWERING TOP, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, FERROSOFERRIC PHOSPHATE, HOPS, POTASSIUM PHOSPHATE, DIBASIC, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, PASSIFLORA INCARNATA FLOWER
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.

Dosage and administration

Adults & children 12 years and over: As a relaxant: swallow 1-2 caplets with water as needed three times daily. For occasional sleeplessness: 1-3 caplets 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 caplet with water as needed three times daily. For occasional sleeplessness: 1-2 caplets 1/2 to 1 hour before retiring.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of occasional sleeplessness and restlessness with accompanying stress, anxiousness, nervousness and irritability.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

OTC - ASK DOCTOR SECTION

Consult a physician if symptoms persist for more than 7 days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

OTC - DO NOT USE SECTION

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

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults & children 12 years and over: As a relaxant: swallow 1-2 caplets with water as needed three times daily. For occasional sleeplessness: 1-3 caplets 1/2 to 1 hour before retiring. Children 6-12 years: As a relaxant: swallow 1 caplet with water as needed three times daily. For occasional sleeplessness: 1-2 caplets 1/2 to 1 hour before retiring.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 32 Caplet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3274-1

HOMEOPATHIC

Natural

Relief

NON-HABIT

FORMING

SINCE 1903

Hyland's ®

Calms Forté ®

Sleep Aid

Relieves stress to help you sleep*

Safe & Effective Relief of:

Occasional Sleeplessness

Restless Sleep

Stress

32 Caplets| Actual Size 356 mg

CartonCarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3274-1CALMS FORTE1 in 1 CARTONTABLET13
54973-3274-1CALMS FORTE32 in 1 BOTTLE, PLASTICTABLET323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3274CALMS 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 [HYLAND'S INC.]3Current NDC, Legacy NDC, 2 package rows20221208_f48a35d4-aa0c-48b1-a2ad-a614ea2894e8.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-327454973-3274-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
STARCH, TAPIOCA24SC3U704IIACT
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
HOPS01G73H6H83ACTIB
POTASSIUM PHOSPHATE, DIBASICCI71S98N1ZACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE70WT22SF4BACTIB
PASSIFLORA INCARNATA FLOWERK8F3G29S6ZACTIB

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALMS FORTEAVENA 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 FLOWERHyland's Inc.f48a35d4-aa0c-48b1-a2ad-a614ea2894e82022-12-07WarningsExact identifier
ndc (package): 54973-3274-1
ndc (product): 54973-3274
ndc11 (package): 54973327401
spl id: ef42fef9-4849-0874-e053-2a95a90a4e80
spl set id: f48a35d4-aa0c-48b1-a2ad-a614ea2894e8

Reported adverse events (FAERS/openFDA)#

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