Calms Forte

Calms Forte
SPL v10
SPL
SPL Set ID 63ce9942-a299-4d9b-b63b-35b297472dc9
Route
ORAL
Published
Effective Date 2024-08-28
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: round Color: white Size: 9 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2016-04-29

Description

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


Medication Information

Description

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

Uses

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

Section 43683-2

Dosage and Administration

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.

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

■ 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.

Questions?

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

Inactive Ingredients

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

If Pregnant Or Breastfeeding

Ask a health professional before use.

Stop Use and Ask A Doctor If

Symptoms persist more than 7 days or worsen.

Principal Display Panel 50 Tablet Bottle Carton

Hyland's

NATURALS™

CALMS

FORTE®

SLEEP AID*

Sleeplessness

Restless Sleep

Stress

Non-Habit

Forming

50

TABLETS

HOMEOPATHIC

Principal Display Panel 100 Tablet Bottle Carton


Structured Label Content

Uses

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

Section 43683-2 (43683-2)

Dosage and Administration

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.

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

■ 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.

Questions?

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

Inactive Ingredients (Inactive ingredients)

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

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

Ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

Symptoms persist more than 7 days or worsen.

Principal Display Panel 50 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 TABLET BOTTLE CARTON)

Hyland's

NATURALS™

CALMS

FORTE®

SLEEP AID*

Sleeplessness

Restless Sleep

Stress

Non-Habit

Forming

50

TABLETS

HOMEOPATHIC

Principal Display Panel 100 Tablet Bottle Carton (PRINCIPAL DISPLAY PANEL - 100 TABLET BOTTLE CARTON)


Advanced Ingredient Data


Raw Label Data

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