CALENDULA OFFICINALIS- calendula off. tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)

Available from:

Hyland's Inc.

INN (International Name):

CALENDULA OFFICINALIS FLOWERING TOP

Composition:

CALENDULA OFFICINALIS FLOWERING TOP 6 [hp_X] in 1 g

Administration route:

SUBLINGUAL

Prescription type:

OTC DRUG

Therapeutic indications:

MINOR CUTS OR SKIN IRRITATION

Authorization status:

unapproved homeopathic

Summary of Product characteristics

CALENDULA OFFICINALIS- CALENDULA OFF. TABLET
HYLAND'S 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._
----------
CALENDULA OFF. 6X
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.
MINOR CUTS OR SKIN IRRITATION
800-624-9659
DIRECTIONS
ADULTS: DISSOLVE 4 TABLETS UNDER TONGUE 4 TIMES A DAY.CHILDREN:
CONSULT
HEALTHCARE PROFESSIONAL.
In a base of Acacia Gum and Lactose N.F.
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
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
Hyland's Inc.
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
MARKET