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

BABY TEETHING by

Drug Labeling and Warnings

BABY TEETHING by is a Homeopathic medication manufactured, distributed, or labeled by CVS PHARMACY, HOMEOLAB USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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.

STORAGE AND HANDLING

Store at room temperature (68-77°F)

Inactive Ingredients

Lactose

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product 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)