AMBRA GRISEA- ambergris pellet

Ambra grisea by

Drug Labeling and Warnings

Ambra grisea by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Ambra grisea

6C,12C,15C,30C,200CK

PURPOSE

INDICATIONS & USAGE

Ocassional sleeplessness with hypersensitivity*

WARNINGS

STOP USE

Stop use and ask a doctor if symptoms persist for more than 3 days or worsen

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding ask a health professional before use

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

DOSAGE & ADMINISTRATION

5 pellets 3 times a day until symptoms are relieved

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken

contains approx 80 pellets

INACTIVE INGREDIENT

lactose, sucrose

QUESTIONS

1-800-BOIRON-1

Newtown Square, PA 19073-3267

info@boironusa.com

SPL UNCLASSIFIED SECTION

These "Uses" have not been evaluated by the FDA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AMBRA GRISEA 
ambergris pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-0221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	6 [hp_C]  in 6 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)

Product Characteristics
Color	white	Score
Shape	ROUND	Size	4mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-0221-41	6 [hp_C] in 1 TUBE; Type 0: Not a Combination Product	03/03/1983

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/03/1983

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-0221)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		380022322	manufacture(0220-0221)