FDA.reportPublic FDA data

Colic Calm

Manufacturer
Denison Pharmaceuticals, Inc.
Effective date
2021-05-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:44:36

Label at a glance#

ProductColic Calm
Active ingredientFENNEL SEED, ACTIVATED CHARCOAL, CHAMOMILE, PRUNUS SPINOSA FLOWER BUD, MENTHA PIPERITA, GINGER, CARAWAY SEED, MELISSA OFFICINALIS
Label structure9 sections

Indications and uses

Temporarily relieves the symptoms of infant: colic, gas, reflux, upset stomach, bloating, hiccups

Dosage and administration

Weight under 20 lbs (9kg) Dose 1/4 teaspoon (1.25 ml) Weight over 20 lbs (9kg) Dose 1/2 teaspoon (2.5 ml) Remove protective wrap from oral dispenser. Shake well before use. Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums. If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours. Recap bottle and clea...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Carbo Vegetabilis 1x, Carum Carvi 3X, Chamomilla 3X, Foeniculum Vulgare 3X, Melissa Officinalis 3X, Mentha Piperita 3x, Prunus Spinosa 3X, Zingiber Officinale 3X

Purpose

OTC - PURPOSE SECTION

  • gas relief, upset stomach
  • digestive aid
  • irritability, hiccups
  • gas relief
  • irritability, restlessness
  • bloating, colic
  • upset stomach, colic
  • digestive aid

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of infant:

colic, gas, reflux, upset stomach, bloating, hiccups

Warnings

WARNINGS SECTION

  • Do not use if protective wrap on oral dispenser is broken or missing.
  • Stop use and consult a doctor if symptoms last more than 7 days or inflammation, fever, or infection occurs.
  • As with all medications, it is important to ensure that your child’s medical professional is aware of the use of this product.
  • As our product is black, a temporary harmless darkening of stool may occur.
  • May stain fabric; take care to protect clothing and furniture.

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

Weight under 20 lbs (9kg) Dose 1/4 teaspoon (1.25 ml)

Weight over 20 lbs (9kg) Dose 1/2 teaspoon (2.5 ml)

  • Remove protective wrap from oral dispenser.
  • Shake well before use.
  • Fill enclosed dispenser up to indicated dose level and dispense liquid slowly (drop by drop) into mouth, between cheek and gums.
  • If needed, repeat every 60 minutes for up to 3 doses. Do not exceed 4 full doses in 24 hours.
  • Recap bottle and clean dispenser after use.
  • Discard remaining product after 3 weeks.

Other Information

SPL UNCLASSIFIED SECTION

  • Please notes: sleep may follow naturally after relief
  • Store at room temperature, out of direct sunlight

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Benzoic acid, citric acid (anhydrous), glycerin, potassium citrate, potassium sorbate, purified water, xantural 180, xytilol

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabel 2label 2

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0295-90280295-9028-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
FENNEL SEEDG3QC02NIE6ACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM CITRATEEE90ONI6FFIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
BENZOIC ACID8SKN0B0MIMIACT
CHAMOMILEFGL3685T2XACTIB
GLYCERINPDC6A3C0OXIACT
PRUNUS SPINOSA FLOWER BUD53Y84VPS2WACTIB
MENTHA PIPERITA79M2M2UDA9ACTIB
GINGERC5529G5JPQACTIB
CARAWAY SEEDW2FH8O2BBEACTIB
MELISSA OFFICINALISYF70189L0NACTIB

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
c2b2accb-cba6-36b5-e053-2995a90a9028b6c40027-cfbd-bff8-e053-2a95a90aeca92021-05-19WarningsExact identifier
spl id: c2b2accb-cba6-36b5-e053-2995a90a9028
spl set id: b6c40027-cfbd-bff8-e053-2a95a90aeca9

Reported adverse events (FAERS/openFDA)#

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