FDA.reportPublic FDA data

Bebelyn Colic

Manufacturer
Pharmadel LLC
Effective date
2022-12-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:43:09

Label at a glance#

ProductBebelyn Colic
Active ingredientCITRULLUS COLOCYNTHIS FRUIT PULP, CHAMOMILE, ACTIVATED CHARCOAL, FENNEL SEED, MAGNESIUM CHLORIDE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, LYCOPODIUM CLAVATUM SPORE
Label structure8 sections

Indications and uses

Bebelyn temporarily relieves the symptoms associted with colic intestinal gas bloating cramping pains hiccups

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*
Carbo vegetabilis 3C...................................................Gas, belching
Chamomilla vularis 5C....................................................Irritability, agitation
Colocynthis 5C................................................Cramping pains, colic
Foeniculum vulgare 5C.......................................Flatulence, hiccups
Magnesia muriaticum 5C........................................Stomach cramps
Magnesia phosphorica 9C..................................Colin in infants
Lycopodium clavatum 5C.....................................................Bloating

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

Uses*

INDICATIONS & USAGE SECTION

Bebelyn temporarily relieves the symptoms associted with colic

  • intestinal gas
  • bloating
  • cramping pains
  • hiccups

Warnings

WARNINGS SECTION

Stop use or ask a doctor if

OTC - ASK DOCTOR SECTION

  • the symptoms are accompanied by high fever (greater than 101°F (38°C)
  • symptoms persis for more than 2 days

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, 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 ColicBebelyn Colic

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
55758-03655758-036-01

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
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
CHAMOMILEFGL3685T2XACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
FENNEL SEEDG3QC02NIE6ACTIB
MAGNESIUM CHLORIDE02F3473H9OACTIB
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEHF539G9L3QACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB

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
0427bffa-8c7c-7724-e063-6294a90ab74a8247ff5c-c3f9-f800-e053-2991aa0a9c482023-01-01WarningsExact identifier
spl set id: 8247ff5c-c3f9-f800-e053-2991aa0a9c48

Reported adverse events (FAERS/openFDA)#

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