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.

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CALMS FORTE

Drug Facts

Active ingredientsPurpose
    Calc. Phos. HPUS 3X, Ferrum Phos. HPUS 3X, Kali Phos. HPUS 3X,
    Mag. Phos. HPUS 3X, Nat. Phos. HPUS 3X
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

Uses

Temporarily relieves the symptoms of simple nervous tension, restless sleep, and occasional sleeplessness.

Warnings

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if:

  • Symptoms persist for more than 7 days or worsen

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

In case of accidental overdose, contact a medical professional or a 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 ½ to 1 hour before retiring.

Children 6 to under 12 years

As a relaxant: Swallow 1 caplet with water as needed three times daily.

For occasional sleeplessness: 1-2 caplets ½ to 1 hour before retiring.

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL - 32 Tablet Bottle Carton

SINCE 1903
Hyland's®

Non-Habit Forming

CALMS FORTÉ®
SLEEP AID

32
Caplets

MADE IN USA

PRINCIPAL DISPLAY PANEL - 32 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:54973-3113
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)  
Product Characteristics
Colorbrown (BEIGE) Scoreno score
ShapeOVALSize9mm
FlavorImprint Code HYL;CF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54973-3113-11 in 1 CARTON10/01/196012/21/2017
132 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2NDC:54973-3113-33 in 1 CARTON10/01/196012/21/2017
2NDC:54973-3113-24 in 1 POUCH; 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(54973-3113) , pack(54973-3113)
Establishment
NameAddressID/FEIBusiness Operations
Merical, Inc.029644978manufacture(54973-3113) , pack(54973-3113)
Establishment
NameAddressID/FEIBusiness Operations
GMP Laboratories of America, Inc.876754375manufacture(54973-3113) , pack(54973-3113)

Revised: 12/2017
 
Hyland's