AMBRA GRISEA by HOMEOLAB USA INC. AMBRA GRISEA pellet

AMBRA GRISEA by

Drug Labeling and Warnings

AMBRA GRISEA by is a Homeopathic medication manufactured, distributed, or labeled by HOMEOLAB USA INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT HPUS

AMBRA GRISEA 2X

(Ambergris)

PURPOSE

FAINTING, RESTLESSNESS

USE

For self-limiting condition listed above or as directed by a health professional.

WARNINGS

Do not use if pellet-dispenser seal is broken.

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

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

Keep out of reach of children.

DIRECTIONS

Adults: Allow 3 or 4 pellets to dissolve in the mouth 3 times a day until symptoms are relieved or as directed by a health professional.

OTHER INFORMATION

Store at room temperature.

INACTIVE INGREDIENTS

Lactose, sucrose.

QUESTIONS?

1-800-404-4666

REFERENCES

The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States.

These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

DESCRIPTION

80 Pellets

Pellet dispenser

Mfd for: HOMEOLAB USA INC., 3025 De L`Assomption, Montreal, QC, H1N 2H2, CANADA

Product of Canada

LABEL

INGREDIENTS AND APPEARANCE

AMBRA GRISEA 
ambra grisea pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-7101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMBERGRIS (UNII: XTC0D02P6C) (AMBERGRIS - UNII:XTC0D02P6C)	AMBERGRIS	2 [hp_X]

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60512-7101-1	80 in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/11/1995

Labeler - HOMEOLAB USA INC. (202032533)

Registrant - HOMEOLAB USA INC. (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC.		202032533	manufacture(60512-7101)