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 Forte

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

Warnings

Stop use and ask a doctor if

Symptoms persist more than 7 days or worsen.

If pregnant or breastfeeding

Ask a health professional before use.

Keep out of reach of children

Directions

■ 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

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

Questions?

www.hylands.com or (800) 624-9659

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON

Hyland's

NATURALS™

CALMS

FORTE®

SLEEP AID*

Sleeplessness

Restless Sleep

Stress

Non-Habit

Forming

50

TABLETS

HOMEOPATHIC

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:54973-3257
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
ShapeROUNDSize9mm
FlavorImprint Code HYL;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3257-11 in 1 CARTON04/29/2016
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3257-2100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2016
3NDC:54973-3257-34 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/29/2016
4NDC:54973-3257-71 in 1 CARTON04/29/2016
4100 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(54973-3257) , pack(54973-3257) , label(54973-3257)

Revised: 12/2022
Document Id: ef42f70d-e49a-eadd-e053-2995a90ab730
Set id: 63ce9942-a299-4d9b-b63b-35b297472dc9
Version: 7
Effective Time: 20221207
 
Hyland's Inc.