INFANTS TEETHING LIQUID- chamomilla, arnica montana, borax, hypericum perforatum liquid

INFANTS TEETHING LIQUID by

Drug Labeling and Warnings

INFANTS TEETHING LIQUID 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 (German chamomile) 5C

Arnica montana (Leopard's bane) 5C

Borax (Sodium borate) 5C

Hypericum perforatum (St.John's wort) 5C

Purpose

Chamomilla (German chamomile) 5C .....................................................gum pain, restlessness, irritability and agitation

Arnica montana (Leopard's bane) 5C ......................................................toothache and fever

Borax (Sodium borate) 5C .....................................................................gum inflammation and diarrhea

Hypericum perforatum (St.John's wort) 5C ..............................................dental nerve pain

REFERENCES

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

Uses

This homeopathic medicine is made from a combination of ingredients traditionally used to help relieve indispositions caused by teething:

• gum inflammation
• gum pain
• fever
• diarrhea
• restlessness and irritability

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

Warnings

Do not use if seal under bottle cap is broken or missing.

Stop use and ask a doctor in cases of high fever or if symptoms worsen or persist for more than 3 days.

Keep out of reach of children.

Directions

• Do not use more than directed.
• Do not take with food.
• Take 0.75 mL orally at the onset of pain.
• Repeat every 15 minutes up to 4 times daily then reduce with improvement until pain subsides, or as directed by a healthcare professional.

Age: Infants and children 0 to 9 years of age

Dose: 0.75 mL

Other information

Store at room temperature.

Inactive ingredients

Purified water, sorbitol, sodium benzoate, potassium sorbate, citric acid, orange oil.

REFERENCES

RETAIN CARTON FOR COMPLETE INSTRUCTIONS

CARTON

INGREDIENTS AND APPEARANCE

INFANTS TEETHING LIQUID 
chamomilla, arnica montana, borax, hypericum perforatum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-642
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	5 [hp_C]  in 25 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	5 [hp_C]  in 25 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	5 [hp_C]  in 25 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	5 [hp_C]  in 25 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Product Characteristics
Color		Score
Shape		Size
Flavor	ORANGE	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-642-02	1 in 1 CARTON
1		25 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/25/2014

Labeler - CVS PHARMACY (062312574)

Registrant - HOMEOLAB USA INC (202032533)

Establishment
Name	Address	ID/FEI	Business Operations
HOMEOLAB USA INC		202032533	manufacture(59779-642)