Label: CHILDRENS TEETHING RELIEF- tribasic calcium phosphate - matricaria recutita - arabica coffee bean - rheum officinale root - tablet, chewable
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Contains inactivated NDC Code(s)
NDC Code(s): 47242-0231-1 - Packager: Homeostasis Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated November 14, 2012
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ACTIVE INGREDIENT
Active Ingredients Purpose Calcarea phosphorica 6C, HPUS Relieves slow and difficult teething Chamomilla 6C, HPUS Relieves intense pains of teething Coffea cruda 6C, HPUS Relieves intense pains of teething Rheum officinale 6C, HPUS Relieves difficult teething "HPUS" indicates that the ingredient is officially included in the Homeopathic Pharmacopeia of the United States and the manufacturer has followed all guidelines set forth.
Statement of Identity: Relief of pain associated with children's teething.
- PURPOSE
- Uses
- Warnings
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive Ingredients
- DO NOT USE
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHILDRENS TEETHING RELIEF
tribasic calcium phosphate - matricaria recutita - arabica coffee bean - rheum officinale root - tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:47242-0231 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE 6 [hp_C] MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_C] ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 6 [hp_C] RHEUM OFFICINALE ROOT (UNII: A47JP5ZG9M) (RHEUM OFFICINALE ROOT - UNII:A47JP5ZG9M) RHEUM OFFICINALE ROOT 6 [hp_C] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape ROUND (Heart) Size 5mm Flavor Imprint Code H Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:47242-0231-1 1 in 1 PACKAGE 1 50 in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/01/2009 Labeler - Homeostasis Laboratories, Inc. (010569196)