Pulsatilla by Historical Remedies / Newton Laboratories, Inc. PULSATILLA pellet

Pulsatilla by

Drug Labeling and Warnings

Pulsatilla by is a Homeopathic medication manufactured, distributed, or labeled by Historical Remedies, Newton Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE SECTION

Formulated for colds and nasal congestion.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults4 pellets; Children(4-12 years) 2 pellets; Dissolve under the tongue. Take every half hour as needed, or 4 times a day.

OTC - ACTIVE INGREDIENT SECTION

1% Pulsatilla 12x

OTC - PURPOSE SECTION

Formulated for cough and chest congestion.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Organic beet-derived sucrose; gluten-free, lactose-free, non-GMO

QUESTIONS SECTION

Distributed by Historical Remedies; 122 S Wabasha, Saint Paul, MN 55107; 800-676-6654

www.historicalremedies.com

WARNINGS SECTION

Warning: Consult a doctor if symptoms persist more than 3 days or worsen. If pregnant or nursing, ask a doctor before use. Keep out of reach of children. Do not use if tamper-evident band is missing or broken.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

INGREDIENTS AND APPEARANCE

PULSATILLA 
pulsatilla pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57556-017
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	12 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUCROSE (UNII: C151H8M554)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57556-017-02	14 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	07/06/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/06/2021

Labeler - Historical Remedies (627758634)

Registrant - Newton Laboratories, Inc. (788793610)

Establishment
Name	Address	ID/FEI	Business Operations
Newton Laboratories, Inc.		788793610	manufacture(57556-017)