CALMS 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.

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 FORTÉ ®

Drug Facts

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

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

Warnings

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

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

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.

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

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

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 32 Caplet Bottle Carton

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

Carton

CALMS 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
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3274
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F) AVENA SATIVA FLOWERING TOP4 [hp_X]
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (PHOSPHATE ION - UNII:NK08V8K8HR) TRIBASIC CALCIUM PHOSPHATE3 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA4 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
HOPS (UNII: 01G73H6H83) (HOPS - UNII:01G73H6H83) HOPS4 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE3 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER4 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize14mm
FlavorImprint Code HYL;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3274-11 in 1 CARTON04/29/2016
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/29/2016
Labeler - Hyland's Inc. (008316655)
Establishment
NameAddressID/FEIBusiness Operations
Hyland's Inc.008316655manufacture(54973-3274) , pack(54973-3274) , label(54973-3274)

Revised: 12/2022
Document Id: ef42fef9-4849-0874-e053-2a95a90a4e80
Set id: f48a35d4-aa0c-48b1-a2ad-a614ea2894e8
Version: 3
Effective Time: 20221207
 
Hyland's Inc.