FDA.reportPublic FDA data

Bebelyn Constipation

Manufacturer
Pharmadel LLC
Effective date
2019-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:30:53

Label at a glance#

ProductBebelyn Constipation
Active ingredientLEAD, SILICON DIOXIDE, SULFUR, BRYONIA ALBA ROOT, CHAMOMILE, ALUMINUM OXIDE, STRYCHNOS NUX-VOMICA SEED
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*
Alumina 4C.................................................................Dry hard stool
Bryonia alba 4C...............................................................Large stool
Chamomilla 5C..............................................Constipation, irritability
Nux vomica 4C.......................................Frequent ineffectual urging
Plumbum met 4C.................................................Hard painful stools
Silicea 4C..............................................................Straining for stool
Sulphur 4C...................................................................Painful stools

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:

Constipatio / Estreñimient

WITH CHAMOMILE / CON MANZANILLA

Homeopathic Remedy / Remedio Homeopático

Natural

3 months & older
3 meses y mayores

0.5 FL Oz (15 mL)

ConstipationConstipation

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-03755758-037-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LEAD2P299V784PACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SULFUR70FD1KFU70ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CHAMOMILEFGL3685T2XACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ALUMINUM OXIDELMI26O6933ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB

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
0f2bac06-28eb-c08c-e063-6294a90ad77882472413-ce97-406e-e053-2a91aa0aba1d2024-01-17WarningsExact identifier
spl set id: 82472413-ce97-406e-e053-2a91aa0aba1d

Reported adverse events (FAERS/openFDA)#

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