Drug Labeling and Warnings

Drug Details

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CALCAREA FLUORICA- calc fluor tablet 
STANDARD HOMEOPATHIC COMPANY

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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MINOR HEMORRHOIDS OR BACK PAIN

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Do not use if cap band is missing or broken. If you are pregnant or nursing, consult a licensed health care professional before using this product. If symptoms persist for 7 days or worsen, contact a licensed practitioner. To be used according to label indications and/or standard homeopathic indications

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

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DIRECTIONS: ADULTS: Dissolve 4 tablets under the tongue 4 times a day.

CHILDREN: 2 tablets as above.

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

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800-624-9659

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CALC. FLOUR. 30X

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MINOR HEMORRHOIDS OR BACK PAIN

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Principal Display Panel -- 500 Tablet Bottle
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 health care professional before using 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.
Standard Homeopathic Company
Los Angeles, CA 90061
Questions? 800-624-9659
Standard Homeopathic
Made in the USA Since 1903
NDC # 0360-0083-01
Homeopathic Medicine
CALC. FLOUR. 30X
MINOR HEMORRHOIDS OR BACK PAIN
500 Tablets
DIRECTIONS: ADULTS: Dissolve 4 tablets under the tongue 4 times a day. CHILDREN: 2 tablets as above.
In a base of Acacia Gum and Lactose N.F.
3 00360 00831 0
Lot #: XXXXXX

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CALCAREA FLUORICA 
calc fluor tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0360-0083
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE30 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0360-0083-011 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/17/1997
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/17/1997
Labeler - STANDARD HOMEOPATHIC COMPANY (008316655)
Establishment
NameAddressID/FEIBusiness Operations
STANDARD HOMEOPATHIC COMPANY008316655pack(0360-0083) , manufacture(0360-0083) , label(0360-0083)

Revised: 5/2017
 
STANDARD HOMEOPATHIC COMPANY


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