CALENDULA OFFICINALIS- calendula off. tablet

CALENDULA OFFICINALIS by

Drug Labeling and Warnings

CALENDULA OFFICINALIS by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Made according to the Homeopathic Pharmacopoeia of the United States since 1903.

Warnings

Do not use if cap band is missing or broken.

If you are pregnant or nursing, consult a licensed beforeusing this product.

If symptoms persist for 7 days or worsen, contact a licensed practitioner.

Keep this and all medicines out of the reach of children.

To be used according to label indications and/or standard homeopathic indications.

INDICATIONS & USAGE

MINOR CUTS OR SKIN IRRITATION

QUESTIONS

800-624-9659

Directions

ADULTS: Dissolve 4 tablets under tongue 4 times a day.CHILDREN: Consult healthcare professional.

INACTIVE INGREDIENT

In a base of Acacia Gum and Lactose N.F.

ACTIVE INGREDIENT

CALENDULA OFF. 6X

Principal Display Panel -- 250 Tablet Bottle Label

STANDARD

HOMEOPATHIC

MADE IN THE USA SINCE 1903

NDC # 0360-0090-01

Homeopathic Medicine

CALENDULA OFF.

6X

MINOR CUTS OR SKIN

IRRITATION*

*Claims based on traditional homeopathic

practice, not accepted medical evidence.

Not FDA evaluated.

250 TABLETS

INGREDIENTS AND APPEARANCE

CALENDULA OFFICINALIS 
calendula off. tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0360-0090
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

Product Characteristics
Color	white	Score	score with uneven pieces
Shape	ROUND	Size	5mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0360-0090-01	1 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/17/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/17/1997

Labeler - STANDARD HOMEOPATHIC COMPANY (008316655)

Establishment
Name	Address	ID/FEI	Business Operations
STANDARD HOMEOPATHIC COMPANY		008316655	manufacture(0360-0090) , pack(0360-0090) , label(0360-0090)