Teething

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2022-05-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:01:15

Label at a glance#

ProductTeething HP
Active ingredientATROPA BELLADONNA, SODIUM BORATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, TRIBASIC CALCIUM PHOSPHATE, MATRICARIA RECUTITA, PASSIFLORA INCARNATA FLOWERING TOP, PODOPHYLLUM, SILICON DIOXIDE
Label structure9 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS:

OTC - PURPOSE SECTION

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:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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:

INDICATIONS & USAGE SECTION

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:

INACTIVE INGREDIENT SECTION

Demineralized water, 20% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc.

201 Apple Blvd.

Woodbine, IA 51579   800.868.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

TEETHING HP

1 fl. oz. (30 ml)

Teething HPTeething HP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0325-12022-05-16C16284748780-19d75b9d0-8b4b-f424-e053-dadaa90a57ceDrug Facts:
44911-0325-12022-01-28C16284748780-19d75b9d0-8b4b-f424-e053-dadaa90a57ceDrug Facts:
44911-0325-12020-06-29C16284748780-19d75b9d0-8b4b-f424-e053-dadaa90a57ceDrug Facts:
44911-0325-12020-01-31C16284748780-19d75b9d0-8b4b-f424-e053-dadaa90a57ceDrug Facts:

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-032544911-0325-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
96922096-aae3-4a03-8d2c-187d8911aaff8c8af682-18b7-453b-a009-9f60d6ff16112022-05-16WarningsExact identifier
spl id: 96922096-aae3-4a03-8d2c-187d8911aaff
spl set id: 8c8af682-18b7-453b-a009-9f60d6ff1611

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.