HYOSCYAMUS NIGER- hyoscyamus niger pellet

Hyoscyamus niger by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Hyoscyamus niger 10M

(**contains 0.443 mg of the active ingredient per pellet)

PURPOSE

INDICATIONS & USAGE

Restless sleep*

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

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT

lactose, sucrose

DOSAGE & ADMINISTRATION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

QUESTIONS

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYOSCYAMUS NIGER 
hyoscyamus niger pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-2574
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYOSCYAMUS NIGER (UNII: 4WRK2153H3) (HYOSCYAMUS NIGER - UNII:4WRK2153H3)	HYOSCYAMUS NIGER	10 [hp_M]  in 10 [hp_M]

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

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: 0220-2574-41	10 [hp_M] 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(0220-2574)