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 ingredients	Purpose
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 Strength	stress, nervousness
Chamomilla HPUS 2X	nervous irritability
Humulus Lupulus HPUS 1X Double Strength	occasional sleeplessness
Passiflora HPUS 1X Triple Strength	restless sleep from exhaustion
Biochemic Phosphates	enhances 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3113
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVENA SATIVA FLOWERING TOP (UNII: MA9CQJ3F7F) (AVENA SATIVA FLOWERING TOP - UNII:MA9CQJ3F7F)	AVENA SATIVA FLOWERING TOP	1 [hp_X]
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	2 [hp_X]
HUMULUS LUPULUS STEM (UNII: OU3SJO07MD) (HUMULUS LUPULUS STEM - UNII:OU3SJO07MD)	HUMULUS LUPULUS STEM	1 [hp_X]
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	1 [hp_X]
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM PHOSPHATE	3 [hp_X]
FERROSOFERRIC PHOSPHATE (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7)	FERROSOFERRIC PHOSPHATE	3 [hp_X]
POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z) (PHOSPHATE ION - UNII:NK08V8K8HR)	POTASSIUM PHOSPHATE, DIBASIC	3 [hp_X]
SODIUM PHOSPHATE (UNII: SE337SVY37) (PHOSPHATE ION - UNII:NK08V8K8HR)	SODIUM PHOSPHATE	3 [hp_X]
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	3 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
STARCH, CORN (UNII: O8232NY3SJ)
STARCH, TAPIOCA (UNII: 24SC3U704I)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	brown (BEIGE)	Score	no score
Shape	OVAL	Size	9mm
Flavor		Imprint Code	HYL;CF
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54973-3113-1	1 in 1 CARTON	10/01/1960	12/21/2017
1		32 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC:54973-3113-3	3 in 1 CARTON	10/01/1960	12/21/2017
2	NDC:54973-3113-2	4 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/01/1960	12/21/2017

Labeler - Hyland's (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3113) , pack(54973-3113)

Name	Address	ID/FEI	Business Operations
Establishment
Merical, Inc.		029644978	manufacture(54973-3113) , pack(54973-3113)

Name	Address	ID/FEI	Business Operations
Establishment
GMP Laboratories of America, Inc.		876754375	manufacture(54973-3113) , pack(54973-3113)

Revised: 12/2017

Document Id: 60ced829-a04e-4338-e053-2a91aa0a7900

Set id: 70a3b2aa-566f-4f6a-a400-0d935823dc07

Version: 2

Effective Time: 20171220

Hyland's