BABY TEETHING- chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating 
CVS PHARMACY

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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DRUG FACTS

Active Ingredients HPUS*

Chamomilla 6X

Calcarea phosphorica 6X

Coffea cruda 6X

Belladonna 12X (calculated as 0.0000000000003% alkaloids)

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

PURPOSE

Chamomilla 6X...............................................................................................Irritability

Calcarea phosphorica 6X..................................................................................Teething, dentition

Coffea cruda 6X..............................................................................................Sleeplessness

Belladonna 12X (calculated as 0.0000000000003% alkaloids)...............................Redness and inflammation

USES

Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce redness and inflammation of gums.*

*These claims have not been reviewed by the Food and Drug Administration. They are based on traditional homeopathic practice.

WARNINGS

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if symptoms do not improve in 7 days; swelling, rash or fever develops; irritation, pain or redness persists or worsens.

Keep this and all medications out of the reach of children. In case of emergency or accidental overdose, contact a medical professional or a poison control center immediately.

Do not use more often than directed; for more than 7 days in a row unless directed by a doctor or dentist; if your child has a known allergy to any ingredient in this product.

Do not use if security seal is broken or missing.

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.

Store at room temperature (68-77°F)

Inactive Ingredients

Lactose

image of box

BABY TEETHING 
chamomilla, calcarea phosphorica, coffea cruda, belladonna tablet, orally disintegrating
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X) CHAMOMILE6 [hp_X]  in 135 
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM PHOSPHATE6 [hp_X]  in 135 
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q) COFFEA ARABICA FRUIT6 [hp_X]  in 135 
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J) ATROPA BELLADONNA WHOLE12 [hp_X]  in 135 
Inactive Ingredients
Ingredient NameStrength
LACTOSE (UNII: J2B2A4N98G)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-372-03135 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/06/2014
Labeler - CVS PHARMACY (062312574)
Registrant - HOMEOLAB USA INC (202032533)
Establishment
NameAddressID/FEIBusiness Operations
HOMEOLAB USA INC202032533manufacture(59779-372)

Revised: 1/2014
Document Id: e0a49252-972b-4838-b115-73d67dfdb782
Set id: d4a23ed6-d885-48ef-83e2-fb2c1223da5d
Version: 1
Effective Time: 20140106
 
CVS PHARMACY