CALM AND COLLECTED- piper methysticum root tablet, orally disintegrating
Similasan Corporation

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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Calm and Collected

Drug Facts

Active Ingredients

Piper methysticum (Kava Kava Root) 12X

Purpose

nervousness, restlessness

Active Ingredients

Piper methysticum (Kava Kava Root) 15X

Purpose

nervousness, restlessness

Active Ingredients

Piper methysticum (Kava Kava Root) 30X

Purpose

nervousness, restlessness

Uses*

According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms such as:
• Nervousness
• Restlessness

Warnings

• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

• Do not exceed recommended dosage.

• Not intended for children under 2.

If pregnant, trying to get pregnant or breast feeding, ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if:

symptoms worsen or persist for more than 72 hours

Directions Adults and Children ages 2 and older:

Take 1 tablet every 4 hours, up to 6 times a day. Do not swallow tablets whole, but chew or allow to dissolve in the mouth. Tablet may also be dissolved in a glass of water. Or use as directed by a licensed health care professional.

Other Information

Active ingredients are manufactured according to homeopathic principles.

Inactive Ingredients

Lactose, Magnesium stearate

Questions?

Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com. www.SimilasanUSA.com

*These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

PRINCIPAL DISPLAY PANEL

NDC 59262-606-30
Similasan
Calm &
Collected
Keva Keva
Actives
60 Dissolvable Tablets

PRINCIPAL DISPLAY PANEL
NDC 59262-606-30
Similasan
Calm &
Collected
Keva Keva
Actives
60 Dissolvable Tablets

CALM AND COLLECTED
piper methysticum root tablet, orally disintegrating

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59262-606
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PIPER METHYSTICUM ROOT (UNII: BOW48C81XP) (PIPER METHYSTICUM ROOT - UNII:BOW48C81XP)	PIPER METHYSTICUM ROOT	57 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59262-606-30	60 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2017	03/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/01/2017	03/01/2023

Labeler - Similasan Corporation (111566530)

Revised: 3/2023

Document Id: 5058819d-b3d8-4411-985b-b9623ad221f2

Set id: b3c63baa-31f4-46d5-8d52-780623dd8f98

Version: 2

Effective Time: 20230302

Similasan Corporation