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

INFANTS TEETHING by

Drug Labeling and Warnings

INFANTS 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 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

Irritability

Teething, dentition

Sleeplessness

Redness and pain

Uses

Temporarily relieves the symptoms of simple restlessness and wakeful irritability due to cutting teeth. Helps reduce gum redness and pain.

*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.

Stop use and ask a doctor if:

• symptoms do not improve in 7 days
• swelling, rash of fever develops
• irritation, pain and redness 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/pharmacy 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.

Other information

Store at room temperature (68°-77°F)

Inactive ingredients

Dextrose, maltodextrin, corn starch, crospovidone, magnesium stearate, lactose.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-860
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	6 [hp_X]
CALCIUM PHOSPHATE (UNII: 97Z1WI3NDX) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	6 [hp_X]
COFFEA ARABICA FRUIT (UNII: HOX6BEK27Q) (COFFEA ARABICA FRUIT - UNII:HOX6BEK27Q)	COFFEA ARABICA FRUIT	6 [hp_X]
ATROPA BELLADONNA WHOLE (UNII: DSV74G1P2J) (ATROPA BELLADONNA WHOLE - UNII:DSV74G1P2J)	ATROPA BELLADONNA WHOLE	12 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
CROSPOVIDONE (UNII: 68401960MK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)

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: 59779-860-03	135 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/14/2014

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC. (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC.		202032533	manufacture(59779-860)