FDA.reportPublic FDA data

Calms Forte

Manufacturer
Hyland's Inc.
Effective date
2026-08-13
Label type
HUMAN OTC DRUG LABEL
Version
13
Source
daily-update
Hydrated at
2026-08-18 02:01:46

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 structure10 sections

Indications and uses

■ Temporarily relieves symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability

Dosage and administration

■ Use as directed. Adults and children 12 years and over As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-3 tablets before bedtime. Children 6 years to under 12 years As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness: 1-2 tablets before bedtime.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

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 symptoms of occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness or irritability

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

Symptoms persist more than 7 days or worsen.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed.

Adults and children
12 years and over 		As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times per day. For occasional sleeplessness:
1-3 tablets before bedtime.
Children 6 years
to under 12 years 		As a relaxant: swallow 1 tablet with water until relieved, up to 3 times per day. For occasional sleeplessness:
1-2 tablets before bedtime.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Uses

RECENT MAJOR CHANGES SECTION

occasional sleeplessness or restlessness with accompanying stress, anxiousness, nervousness and irritability. Changed "and" to "or"

RECENT MAJOR CHANGES SECTION

Dosage and Administration

Adults and children

12 years and over

As a relaxant: swallow 1-2 tablets with water until relieved, up to 3 times

per day. For occasional sleeplessness: 1-3 tablets before bedtime.

Children 6 years

to under 12 years

As a relaxant: swallow 1 tablet with water until relieved, up to 3 times

per day. For occasional sleeplessness: 1-2 tablets before bedtime.

PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CAFO00000T50LBLH2

CAFO00000T50LBLH2CAFO00000T50LBLH2

PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HNCF0000T100LBLH2

HNCF0000T100LBLH2HNCF0000T100LBLH2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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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
54973-325754973-3257-1, 54973-3257-2, 54973-3257-3, 54973-3257-7

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
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
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
MAGNESIUM PALMITOSTEARATER4OXA9G5BVIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT
STARCH, TAPIOCA24SC3U704IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
122026-08-11daily-update2026-08-14 00:01:03
102025-04-09full-release2026-06-01 02:33:11

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.63ce9942-a299-4d9b-b63b-35b297472dc92026-08-13WarningsExact identifier
ndc (package): 54973-3257-7
ndc (package): 54973-3257-3
ndc (package): 54973-3257-1
ndc (package): 54973-3257-2
ndc (product): 54973-3257
ndc11 (package): 54973325707
ndc11 (package): 54973325701
ndc11 (package): 54973325703
ndc11 (package): 54973325702
spl id: 58f195ef-ccf8-4142-e063-6394a90aa962
spl set id: 63ce9942-a299-4d9b-b63b-35b297472dc9

Reported adverse events (FAERS/openFDA)#

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