FDA.reportPublic FDA data

Baby Colic Relief

Manufacturer
King Bio Inc
Effective date
2018-03-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:02:38

Label at a glance#

ProductBaby Colic Relief
Active ingredientAETHUSA CYNAPIUM, ALOE, ACTIVATED CHARCOAL, MATRICARIA CHAMOMILLA, CITRULLUS COLOCYNTHIS FRUIT PULP, MENTHA PIPERITA, ANEMONE PULSATILLA, SENNA LEAF, SILICON DIOXIDE, VALERIAN, GINGER
Label structure9 sections

Indications and uses

for temporary relief of symptoms: abdominal discomfort pressure and distention spitting up gas and bloating cramping pain irritability desire to be held constantly weak digestion restless sleep

Dosage and administration

Initially, depress pump until primed Spray one dose directly into mouth Under 6 Months: Consult a licensed healthcare professional before using 6 months to 2 years: 1 spray every 15 minutes, up to 4 doses, then hourly until relieved 2 years and older: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Aethusa cynapium, Aloe, Carbo vegetabilis, Chamomilla, Colocynthis, Mentha piperita, Pulsatilla, Senna, Silicea, Valeriana officinalis, Zingiber officinale

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Initially, depress pump until primed
  • Spray one dose directly into mouth

Under 6 Months: Consult a licensed healthcare professional before using

6 months to 2 years: 1 spray every 15 minutes, up to 4 doses, then hourly until relieved

2 years and older: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Purpose

OTC - PURPOSE SECTION

Aethusa cynapium.............restlessness, irritability

Aloe................................gas reief, bloating, colic before & after stool

Carbo vegetabilis..............gas with colic, upset stomach

Chamomilla......................irritability, ooversensitivity

Colocynthis......................abdominal discomfort

Mentha piperita.................infantile colic, accumulation of gas

Pulsatilla...........................stomach cramps, desire to be held

Senna..............................colic, gas, constipation

Silicea..............................belching, colic

Valeriana officinalis.............irritability, bloating, sleeplessness

Zingiber officinale................digestive aid, colic pain, flatulence

Warnings

WARNINGS SECTION

Stop use and ask a doctor, if symptoms persist or worsen

If pregnant or breast-feeding, ask a healthcare professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Other Information

OTHER SAFETY INFORMATION

This product is intended to compliment, not replace, standard medical care.

Tamper resistant for your protection. Use only if safety seal is intact.

Uses

INDICATIONS & USAGE SECTION

for temporary relief of symptoms:

  • abdominal discomfort
  • pressure and distention
  • spitting up
  • gas and bloating
  • cramping
  • pain
  • irritability
  • desire to be held constantly
  • weak digestion
  • restless sleep

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-0466-22023-04-03C16284748780-19d75b9d0-c1ab-f424-e053-dadaa90a57ceBaby Colic Relief
57955-0466-22020-01-31C16284748780-19d75b9d0-c1ab-f424-e053-dadaa90a57ceBaby Colic Relief

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-046657955-0466-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AETHUSA CYNAPIUMM6936L953CACTIB
ALOEV5VD430YW9ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
CITRULLUS COLOCYNTHIS FRUIT PULP23H32AOH17ACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SENNA LEAFAK7JF626KXACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
VALERIANJWF5YAW3QWACTIB
GINGERC5529G5JPQACTIB
CARYA OVATA BARKX765CF609LIACT
CITRUS BIOFLAVONOIDSBD70459I50IACT
LONICERA JAPONICA FLOWER4465L2WS4YIACT
POLYEPSILON-LYSINE (4000 MW)WB0M8X4TWRIACT
REBAUDIOSIDE AB3FUD0528FIACT
WATER059QF0KO0RIACT

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
df87fc4c-49b2-4292-951d-43776f6fea93b1030fb4-b142-4618-a8b0-5e5abd526ab22023-04-03WarningsExact identifier
spl set id: b1030fb4-b142-4618-a8b0-5e5abd526ab2

Reported adverse events (FAERS/openFDA)#

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