TEETHING- chamomilla, arnica montana, borax, hypericum perforatum tablet, chewable

TEETHING by

Drug Labeling and Warnings

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 5C

Arnica montana 5C

Borax 5C

Hypericum perforatum 5C

PURPOSE

Gum pain, irritability

Teething, fever

Gum inflammation, diarrhea

Dental nerve pain

REFERENCES

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

USES

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

WARNINGS

Do not use

• more often than directed
• for more than 7 days in a row unless directed by doctor or dentist
• if your child has known allergy to any ingredient in this product

Stop use and ask a doctor if

• symptoms do not improve in 7 days
• swelling, rash or fever develops
• irritation, pain or redness persists or worsens

Keep out of reach of children. In case of accidental overdose, contact a medical professional or a poison control center immediately. Do not use if imprinted tamper band is broken or missing.

DIRECTIONS

Dissolve 2 to 3 tablets under the tongue 4 times per day. If you prefer, tablets may be dissolved in a teaspoon of water and then given to the child. If the child is restless or wakeful, 2 tablets every hour for 6 doses or as recommended by a doctor. Teething tablets are very soft and dissolve almost instantly under the tongue. Please note: if your baby has been crying or upset, your baby may fall asleep after using this product because the pain has been relieved and your child can rest.

• AGE: DOSE
• infants and children up to 9 years of age: 2 to 3 tablets

OTHER INFORMATION

In case of emergency, contact a medical professional.

INACTIVE INGREDIENTS

Lactose NF.

IMAGE CARTON LABEL

INGREDIENTS AND APPEARANCE

TEETHING 
chamomilla, arnica montana, borax, hypericum perforatum tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-209
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	5 [hp_C]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	5 [hp_C]
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	5 [hp_C]
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	5 [hp_C]

Inactive Ingredients
Ingredient Name	Strength
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: 59779-209-05	135 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		05/01/2013

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(59779-209)