FDA.reportPublic FDA data

Bebelyn Teething

Manufacturer
Pharmadel LLC
Effective date
2019-02-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:30:52

Label at a glance#

ProductBebelyn Teething
Active ingredientMAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE, CHAMOMILE, ACONITUM NAPELLUS, TRIBASIC CALCIUM PHOSPHATE
Label structure8 sections

Indications and uses

temporarily relieves the symptoms of simple restlessness wakeful irritability due to teething helps reduce gum redness and inflammation

Dosage and administration

do not use more than directed children 3 months and older: 10 drops directly on the tongue or diluted in a little water, every 4 hours or as needed to preserve purity, do not touch the tip of dropper with the mouth

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients** (HPUS)Purposes*
Aconitum 6C...................................................Acute pain, with fever
Calcarea phos 6C..................................................Teething difficulty
Chamomilla 5C, 15C...........................................Teething, irritability
Magnesia phos 6C......................................................Teething pain

The letters “HPUS” indicate that this ingredient is officially included in the
Homeopathic Pharmacopeia of the United States

Uses*

INDICATIONS & USAGE SECTION

  • temporarily relieves the symptoms of
  • simple restlessness
  • wakeful irritability due to teething
  • helps reduce gum redness and inflammation

Warnings

WARNINGS SECTION

Stop use or ask a doctor if

OTC - ASK DOCTOR SECTION

  • symptoms are accompanied by high fever (greater than 101°F (38°C)
  • swelling or rash develops
  • symptoms do not improve within 3 days or worsens

KEEP OUT OF THE REACH OF CHILDREN.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an accidental overdose, seek medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not use more than directed
  • children 3 months and older: 10 drops directly on the tongue or diluted in a little water, every 4 hours or as needed
  • to preserve purity, do not touch the tip of dropper with the mouth

Other Information

OTHER SAFETY INFORMATION

  • store at 68-77°F (20-25°C)
  • protect from excessive heat or direct sun
  • TAMPER EVIDENT: Do not use if neck band is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, glycerin USP, potassium sorbate, purified water.

Questions or comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F)
9 AM to 5 PM Eastern or www.pharmadel.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bebelyn

Relieves / Alivia:

Teething pain/ Denticion

WITH CHAMOMILE / CON MANZANILLA

Homeopathic Remedy / Remedio Homeopático

Natural

3 months & older
3 meses y mayores

0.5 FL Oz (15 mL)

Bebelyn TeethingBebelyn Teething

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-03855758-038-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MAGNESIUM PHOSPHATE, TRIBASIC, PENTAHYDRATE453COF7817ACTIB
CHAMOMILEFGL3685T2XACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28ACTIM

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
0f2be35e-0bd8-41d4-e063-6294a90a8829824523d7-d8d3-2fed-e053-2991aa0ac8a62024-01-17WarningsExact identifier
spl set id: 824523d7-d8d3-2fed-e053-2991aa0ac8a6

Reported adverse events (FAERS/openFDA)#

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