Package Insert and Label Information: Teething Formula

By Apotheca Company | Last revised: 1 February 2011

TEETHING FORMULA — oyster shell calcium carbonate, crude, tribasic calcium phosphate, magnesium phosphate, dibasic trihydrate, phytolacca americana root, pulsatilla vulgaris and rheum officinale root liquid
Apotheca Company

ACTIVE INGREDIENTS: Calcarea carbonica 8X, Calcarea phosphorica 8X, Magnesia phosphorica 8X, Phytolacca decandra 30C, Pulsatilla 30C, Rheum 30C.

TO BE USED FOR FURTHER MANUFACTURING, PROCESSING, OR REPACKING.

WARNINGS: If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medial help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

TO BE DETERMINED BY FINAL PROCESSOR.

INACTIVE INGREDIENTS: Demineralized water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN. In case of overdose, get medical help or contact a Poison Control Center right away.

TO BE USED FOR FURTHER MANUFACTURING, PROCESSING, OR REPACKING.

MFG. For:

Formulae Development

8 Crown Plaza, Suite 103

Hazlet, NJ 07730

732-335-8800

CAUTION: FOR MANUFACTURING, PROCESSING, OR REPACKING

TEETHING FORMULA

HOMEOPATHIC

(click image for full-size original)

TEETHING FORMULA
calcarea carbonica, calcarea phosphorica, magnesia phosphorica, phytolacca decandra, pulsatilla, rheum, liquid

Product Information
Product Type	BULK INGREDIENT	Item Code (Source)	NDC:57520-0433
Route of Administration	NOT APPLICABLE	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	8 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION)	TRIBASIC CALCIUM PHOSPHATE	8 [hp_X] in 1 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	8 [hp_X] in 1 mL
PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT)	PHYTOLACCA AMERICANA ROOT	30 [hp_C] in 1 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS)	PULSATILLA VULGARIS	30 [hp_C] in 1 mL
RHEUM OFFICINALE ROOT (RHEUM OFFICINALE ROOT)	RHEUM OFFICINALE ROOT	30 [hp_C] in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
ALCOHOL

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:57520-0433-4	20000 mL in 1 JUG	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Drug for Further Processing		05/28/2010

Labeler — Apotheca Company (844330915)

Establishment
Name	Address	ID/FEI	Operations
Apotheca Company		844330915	manufacture

Revised: 02/2011 Apotheca Company