CALM AND COLLECTED- piper methysticum root tablet, orally disintegrating

Calm and Collected by

Drug Labeling and Warnings

Calm and Collected by is a Homeopathic medication manufactured, distributed, or labeled by Similasan Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

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

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

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

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED HOMEOPATHIC		02/01/2017

Labeler - Similasan Corporation (111566530)