Teething Hp (Belladonna, Borax, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Passiflora Incarnata, Podophyllum Peltatum, Silicea) Liquid [Energique, Inc.] -

TEETHING HP (BELLADONNA, BORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLUM PELTATUM, SILICEA) LIQUID [ENERGIQUE, INC.]
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NDC	44911-0325-1
Set ID	8c8af682-18b7-453b-a009-9f60d6ff1611
Category	HUMAN OTC DRUG LABEL
Packager	Energique, Inc.
Generic Name
Product Class
Product Number
Application Number

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ACTIVE INGREDIENTS:

Belladonna 30X, Borax 30X, Calcarea Carbonica 30X, Calcarea Phosphorica 30X, Chamomilla 30X, Passiflora Incarnata 30X, Podophyllum Peltatum 30X, Silicea 30X.
INDICATIONS:

For temporary relief of symptoms due to teething.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
WARNINGS:

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical 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.
KEEP OUT OF REACH OF CHILDREN:

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

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.
INDICATIONS:

For temporary relief of symptoms due to teething.**

**These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
INACTIVE INGREDIENTS:

Demineralized water, 20% Ethanol.
QUESTIONS:

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579 800.868.8078
PACKAGE LABEL DISPLAY:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TEETHING HP

1 fl. oz. (30 ml)

INGREDIENTS AND APPEARANCE

TEETHING HP
belladonna, borax, calcarea carbonica, calcarea phosphorica, chamomilla, passiflora incarnata, podophyllum peltatum, silicea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:44911-0325
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H)	ATROPA BELLADONNA	30 [hp_X] in 1 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	30 [hp_X] in 1 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	30 [hp_X] in 1 mL
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	30 [hp_X] in 1 mL
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	30 [hp_X] in 1 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	30 [hp_X] in 1 mL
PODOPHYLLUM (UNII: 2S713A4VP3) (PODOPHYLLUM - UNII:2S713A4VP3)	PODOPHYLLUM	30 [hp_X] in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	30 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:44911-0325-1	30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	02/23/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		02/23/2016

Labeler - Energique, Inc. (789886132)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(44911-0325) , api manufacture(44911-0325) , label(44911-0325) , pack(44911-0325)

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Medic

TEETHING HP (BELLADONNA, BORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLUM PELTATUM, SILICEA) LIQUID [ENERGIQUE, INC.]

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