CALMS FORTE- avena sativa flowering top, chamomile, humulus lupulus stem, passiflora incarnata flower, calcium phosphate, ferrosoferric phosphate, potassium phosphate, dibasic, sodium phosphate, and magnesium phosphate, dibasic trihydrate tablet 
Hyland's

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.

----------

CALMS FORTÉ ®

Drug Facts

Active IngredientsPurpose
Avena Sativa HPUS 1X Double Strengthstress, nervousness
Chamomilla HPUS 2Xnervous irritability
Humulus Lupulus HPUS 1X Double Strengthoccasional sleeplessness
Passiflora HPUS 1X Triple Strengthrestless sleep from exhaustion
Biochemic Phosphatesenhances cellular function
  Calc. Phos HPUS 3X, Ferrum Phos HPUS 3X, Kali Phos HPUS 3X,
  Mag. Phos HPUS 3X, Nat. Phos HPUS 3X

Uses

  • Temporarily relieves the symptoms of simple nervous tension and occasional sleeplessness.

Warnings

Ask a doctor before use if pregnant or nursing.

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

Keep out of the reach of children.

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

In case of accidental overdose, contact a poison control center immediately. In case of emergency, Hyland's may be contacted 24 hours a day, 7 days a week at 800/624-9659.

Directions

Adults: As a relaxant: 1 to 2 tablets with water as needed three times daily. For Occasional Sleeplessness: 1 to 3 tablets 1/2 to 1 hour before retiring. Children 6-12 years: 1/2 adult dose.

Inactive Ingredients

Lactose N.F.,Starch (Corn and Tapioca), Vegetable Magnesium Stearate.

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

Hyland's®
HOMEOPATHIC
SINCE 1903

CALMS
FORTÉ ®

SLEEP AID

50
Tablets

Principal Display Panel - 50 Tablet Bottle Carton

PRINCIPAL DISPLAY PANEL - 50 Tablet Bottle Carton

Hyland's®

CALMS
FORTÉ ®

SLEEP AID

50
Tablets

Principal Display Panel - 50 Tablet Bottle Carton
CALMS FORTE 
avena sativa flowering top, chamomile, humulus lupulus stem, passiflora incarnata flower, calcium phosphate, ferrosoferric phosphate, potassium phosphate, dibasic, sodium phosphate, and magnesium phosphate, dibasic trihydrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-1121
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 TOP1 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]
HUMULUS LUPULUS STEM (UNII: OU3SJO07MD) (HUMULUS LUPULUS STEM - UNII:OU3SJO07MD) HUMULUS LUPULUS STEM1 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER1 [hp_X]
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE3 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
SODIUM PHOSPHATE (UNII: SE337SVY37) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE3 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
Colorbrown (BEIGE) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code HYL;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-1121-21 in 1 CARTON10/01/196012/21/2017
1100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-1121-11 in 1 CARTON10/01/196012/21/2017
250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
3NDC:54973-1121-54 in 1 POUCH; Type 0: Not a Combination Product10/01/196012/21/2017
4NDC:54973-1121-41 in 1 CARTON10/01/196012/21/2017
4250 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/196012/21/2017
CALMS FORTE 
avena sativa flowering top, chamomile, humulus lupulus stem, passiflora incarnata flower, calcium phosphate, ferrosoferric phosphate, potassium phosphate, dibasic, sodium phosphate, and magnesium phosphate, dibasic trihydrate tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3146
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 TOP1 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE2 [hp_X]
HUMULUS LUPULUS STEM (UNII: OU3SJO07MD) (HUMULUS LUPULUS STEM - UNII:OU3SJO07MD) HUMULUS LUPULUS STEM1 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z) PASSIFLORA INCARNATA FLOWER1 [hp_X]
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE3 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERROSOFERRIC PHOSPHATE3 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR) POTASSIUM PHOSPHATE, DIBASIC3 [hp_X]
SODIUM PHOSPHATE (UNII: SE337SVY37) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE3 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE3 [hp_X]
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
STARCH, CORN (UNII: O8232NY3SJ)  
STARCH, TAPIOCA (UNII: 24SC3U704I)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ACACIA (UNII: 5C5403N26O)  
Product Characteristics
Colorbrown (BEIGE) Scoreno score
ShapeROUNDSize9mm
FlavorImprint Code HYL;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3146-150 in 1 CARTON10/01/196012/21/2017
150 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic10/01/196012/21/2017
Labeler - Hyland's (028570695)
Establishment
NameAddressID/FEIBusiness Operations
Standard Homeopathic Company008316655manufacture(54973-1121, 54973-3146) , pack(54973-1121, 54973-3146)
Establishment
NameAddressID/FEIBusiness Operations
Merical, Inc.029644978manufacture(54973-1121) , pack(54973-1121)

Revised: 12/2017
Document Id: 60dd23d7-e55d-2a35-e053-2991aa0ae331
Set id: da41b2f8-9b82-4b00-ad23-02af045c31da
Version: 3
Effective Time: 20171221
 
Hyland's