Teething Formula: Package Insert and Label Information

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

Teething Formula
(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

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