Belladonna: Homeopathic Product Information

BELLADONNA- atropa belladonna pellet
Historical Remedies

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

INDICATIONS & USAGE SECTION

Formulated for sore throat.

DOSAGE & ADMINISTRATION SECTION

Directions: Adults 4 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% Belladonna 12x

OTC — PURPOSE SECTION

Formulated for sore throat.

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

package label
(click image for full-size original)

BELLADONNA
belladonna pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57556-012
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ATROPA BELLADONNA (ATROPA BELLADONNA) ATROPA BELLADONNA 12 [hp_X] in 1 g
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:57556-012-02 14 g in 1 BOTTLE, GLASS None
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 Operations
Newton Laboratories, Inc. 788793610 manufacture (57556-012)

Revised: 07/2021 Historical Remedies

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