AMYL NITROSUM by HOMEOLAB USA INC. AMYL NITROSUM pellet

AMYL NITROSUM by

Drug Labeling and Warnings

AMYL NITROSUM 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

AMYL NITROSUM 6X

Amyl Nitrite

PURPOSE

HOT FLASHES WITH COLD CHILLS*

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.

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

3025 De L'Assomption, Montreal, QC, H1N 2H2, CANADA

1-800-404-4666 / www.homeolab.com

Product of Canada

LABEL

INGREDIENTS AND APPEARANCE

AMYL NITROSUM 
amyl nitrosum pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60512-6179
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AMYL NITRITE (UNII: 22T8Z09XAK) (AMYL NITRITE - UNII:22T8Z09XAK)	AMYL NITRITE	6 [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: 60512-6179-1	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(60512-6179)