Ambra grisea

Manufacturer: Boiron | Boiron, Inc.
Effective date: 2018-03-28
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:00:29

Label at a glance#

ProductAmbra grisea

Active ingredientAMBERGRIS

Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Ambra grisea

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

INDICATIONS & USAGE SECTION

Ocassional sleeplessness with hypersensitivity*

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

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 SECTION

lactose, sucrose

OTC - QUESTIONS SECTION

1-800-BOIRON-1

Newtown Square, PA 19073-3267

info@boironusa.com

SPL UNCLASSIFIED SECTION

These "Uses" have not been evaluated by the FDA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Ambra grisea
AMBERGRIS
SUCROSE
LACTOSE, UNSPECIFIED FORM
ANHYDROUS LACTOSE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0220-0221	0220-0221-41

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AMBERGRIS	XTC0D02P6C	ACTIB
SUCROSE	C151H8M554	IACT
LACTOSE, UNSPECIFIED FORM	J2B2A4N98G	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
b325563c-b72b-21ff-e053-2995a90a0216			687e64ac-7270-c2b2-e053-2a91aa0a1f4e	2020-11-02		Exact identifier spl set id: 687e64ac-7270-c2b2-e053-2a91aa0a1f4e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.