Calms Forté ®

Calms Forté ®
SPL v3
SPL
SPL Set ID f48a35d4-aa0c-48b1-a2ad-a614ea2894e8
Route
ORAL
Published
Effective Date 2016-04-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avena Sativa Flowering Top (4 [hp_X]) Phosphate Ion (3 [hp_X]) Matricaria Recutita Ferrosoferric Phosphate Hops Magnesium Cation Passiflora Incarnata Flower
Inactive Ingredients
Lactose, Unspecified Form Magnesium Palmitostearate Cellulose, Microcrystalline Starch, Corn Starch, Tapioca

Identifiers & Packaging

Pill Appearance
Imprint: HYL;CF Shape: oval Color: white Size: 14 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-04-29

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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.

Section 50569-3

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

Section 50570-1

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.

Section 53414-9

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

Section 55105-1
Active ingredients Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUS stress, nervousness
Calcarea Phosphorica 3X HPUS restlessness
Chamomilla 4X HPUS nervous irritability
Ferrum Phosphoricum 3X HPUS nervousness
Humulus Lupulus 4X HPUS occasional sleeplessness
Kali Phosphoricum 3X HPUS irritability
Magnesia Phosphorica 3X HPUS mental anxiousness
Natrum Phosphoricum 3X HPUS anxiousness
Passiflora 4X HPUS restless sleep from exhaustion
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


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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.

Section 50569-3 (50569-3)

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

Section 50570-1 (50570-1)

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.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients Purpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Avena Sativa 4X HPUS stress, nervousness
Calcarea Phosphorica 3X HPUS restlessness
Chamomilla 4X HPUS nervous irritability
Ferrum Phosphoricum 3X HPUS nervousness
Humulus Lupulus 4X HPUS occasional sleeplessness
Kali Phosphoricum 3X HPUS irritability
Magnesia Phosphorica 3X HPUS mental anxiousness
Natrum Phosphoricum 3X HPUS anxiousness
Passiflora 4X HPUS restless sleep from exhaustion
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 (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

(800) 624-9659

Principal Display Panel 32 Caplet Bottle Carton (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


Advanced Ingredient Data


Raw Label Data

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