BELLADONNA- belladonna tablet
Schwabe North America, Inc

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.

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Belladonna 6X

Active Ingredients:

Belladonna 6X

Inactive Ingredients:
Cellulose
Croscarmellose sodium
Lactose
Magnesium stearate

Dosage and Administration:

Boericke and Tafel Brand

Directions: Adults or children over 2 years: Take 3 tablets 4-6 times a day.

Allow to dissolve under tongue.

Stop when symptoms are relieved.

Indications and Usage:

For temporary relief of nasal congestion, sore throat, or headache associated with a cold or flu.

Warnings:

If nasal symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor.

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

Pregnancy or Breast Feeding:

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

Keep Out of Reach of Children:

Keep out of reach of children.

Ask the Doctor:

If nasal symptoms do not improve within 7 days or are accompanied by a fever, consult a doctor.

Do not take this product for pain for more than 10 days (adult) or 5 days (children) unless directed by a doctor.

If pain persists or gets worse, if new symptoms occur, or if redness or swelling is present, consult a doctor because these could be signs of a serious condition.

Overdosage:

In case of overdose, seek medical help or contact a Poison Control Center immediately.

Purpose:

For the temporary relief of nasal congestion, sore throat, or headache associated with a cold or flu.

Package Label and Principal Display: Boericke and Tafel Brand 21105533

21105533 02 Belladonna 6X 100ct 100.jpg

BELLADONNA
belladonna tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53499-5533
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)

Product Characteristics
Color	white (Small round white tablet)	Score	no score
Shape	ROUND (B&T)	Size	6mm
Flavor		Imprint Code	B;T
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53499-5533-2	100 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2006	04/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/01/2006	04/30/2019

Labeler - Schwabe North America, Inc (831153908)

Name	Address	ID/FEI	Business Operations
Establishment
Schwabe Mexico, S.A. de C.V.		812805901	manufacture(53499-5533)

Revised: 11/2017

Document Id: 08cb67d7-7e4c-41e4-92f6-18f93c117bf1

Set id: 2744a0e5-cdd1-46e8-b023-931873d7e728

Version: 4

Effective Time: 20171108

Schwabe North America, Inc