Colic Relief

Manufacturer
CVS Pharmacy | Apotheca Company
Effective date
2016-02-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:07:30

Label at a glance#

ProductColic Relief
Active ingredientALOE, ACTIVATED CHARCOAL, CARAWAY SEED, MATRICARIA RECUTITA, FENNEL SEED, MELISSA OFFICINALIS, MENTHA PIPERITA, PRUNUS SPINOSA FLOWER BUD, GINGER
Label structure10 sections

Indications and uses

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

Dosage and administration

• SHAKE WELL before use to obtain uniform dark mixture. • Remove outer imprinted safety seal from glass bottle and protective wrap on oral dispenser. • When symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums. • If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed 4 full dos...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aloe 5X, Carbo Vegetabilis 1X, Carum Carvi 5X, Chamomilla 5X, Foeniculum Vulgare 5X, Melissa Officinale 5X, Mentha Piperita 5X, Prunus Spinosa 5X, Zingiber Officinale5X.

USES:

OTC - PURPOSE SECTION

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

WARNINGS:

WARNINGS SECTION

• DO NOT USE IF OUTER IMPRINTED SAFETY SEAL ON GLASS BOTTLE OR PROTECTIVE WRAP ON ORAL DISPENSER ARE 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.

• Because product is black, a temporarily, harmless, darkening of the stool may occur.

• May stain fabric; protect clothing and furniture.

KEEP OUT OF REACH OF CHILDREN:

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

• SHAKE WELL before use to obtain uniform dark mixture.
• Remove outer imprinted safety seal from glass bottle and protective wrap on oral dispenser.
• When symptoms occur, fill enclosed oral dispenser up to indicated dose level and dispense liquid slowly, drop-by-drop into mouth, between cheek and gums.
• If needed, repeat every 30 minutes for up to 3 doses, or as directed by a physician. Do not exceed 4 full doses in 24 hours.
• Recap glass bottle and clean oral dispenser.

Weight              Dose
Under 20 lbs.    1/4 teaspoon (1.25 mL)
Over 20 lbs.      1/2 teaspoon (2.5 mL)

OTHER SAFETY INFORMATION:

OTHER SAFETY INFORMATION

Please note: Sleep may follow naturally after relief.

STORE AT ROOM TEMPERATURE, OUT OF DIRECT SUNLIGHT.

INDICATIONS:

INDICATIONS & USAGE SECTION

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerin, Potassium Benzoate, Potassium Citrate, Potassium Sorbate, Purified Water, Xylitol.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

©2015 CVS/Pharmacy

CVS.com

1-800-SHOP CVS

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS        NDC 59779-542-01
Health

Safe & Fast-Acting
Colic Relief
HOMEOPATHIC MEDICINE
ORAL SUSPENSION
Great Tasting
• Relieves gas & Colic
• Soothes upset stomach
• No artificial flavors
or colors

2 FL OZ (59 mL)

Colic Relief labelColic Relief label

Colic Relief cartonColic Relief carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-542-012020-01-31C16284748780-19d75b9d0-5ed5-f424-e053-dadaa90a57ceDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-542-01Colic Relief1 in 1 CARTONLIQUID12
59779-542-01Colic Relief59 mL in 1 BOTTLE, WITH APPLICATORLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-542COLIC RELIEF (ALOE, CARBO VEGETABILIS, CARUM CARVI, CHAMOMILLA, FOENICULUM VULGARE, MELISSA OFFICINALE, MENTHA PIPERITA, PRUNUS SPINOSA, ZINGIBER OFFICINALE) LIQUID [CVS PHARMACY]2Legacy NDC, 2 package rows20160212_9f48b00b-ca55-4f45-9f64-64254ba6b764.zip

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
59779-54259779-542-01

Ingredients#

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

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

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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