Label: BABY TEETHING- chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating
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Contains inactivated NDC Code(s)
NDC Code(s): 59779-372-03 - Packager: CVS PHARMACY
- 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 January 6, 2014
If you are a consumer or patient please visit this version.
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- ACTIVE INGREDIENT
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PURPOSE
Chamomilla 6X...............................................................................................Irritability
Calcarea phosphorica 6X..................................................................................Teething, dentition
Coffea cruda 6X..............................................................................................Sleeplessness
Belladonna 12X (calculated as 0.0000000000003% alkaloids)...............................Redness and inflammation
- USES
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WARNINGS
Consult a physician if symptoms do not improve in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or worsens.
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DIRECTIONS
Allow 2 or 3 tablets to dissolve under the tongue 4 times a day, or as directed by a licensed health care professional. If the child is restless or wakeful, allow 2 tablets to dissolve under the tongue every hour for 6 doses, or as directed by a licensed health care professional. If preferred, tablets may be dissolved in a teaspoon of water and then given to the child. CVS Teething Tablets are very soft and will dissolve almost instantly in the mouth. Please note: if your child has been crying or is upset, your child may fall asleep after using this product because the pain has been relieved and your child can rest.
- STORAGE AND HANDLING
- Inactive Ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
BABY TEETHING
chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegratingProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE 6 [hp_X] in 135 CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE 6 [hp_X] in 135 COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT 6 [hp_X] in 135 ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE 12 [hp_X] in 135 Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND Size 5mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-372-03 135 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 01/06/2014 Labeler - CVS PHARMACY (062312574) Registrant - HOMEOLAB USA INC (202032533) Establishment Name Address ID/FEI Business Operations HOMEOLAB USA INC 202032533 manufacture(59779-372)