Active Ingredients:
Aloe 5X, Carbo Vegetabilis 1X, Carum Carvi 5X, Chamomilla 5X, Foeniculum Vulgare 5X, Melissa Officinale 5X, Mentha Piperita 5X, Prunus Spinosa 5X, Zingiber Officinale5X.
Colic Relief
FDA Label NDC 59779-542
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cvs Pharmacy for the product Colic Relief (NDC 59779-542). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients:, uses:, warnings:, keep out of reach of children:, directions:, other safety information:, indications:, inactive ingredients:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
Temporarily relieves the symptoms of infant gas, colic, upset stomach, bloating, hiccups.
Warnings:
• 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:
KEEP OUT OF REACH OF CHILDREN.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions:
• 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:
Please note: Sleep may follow naturally after relief.
STORE AT ROOM TEMPERATURE, OUT OF DIRECT SUNLIGHT.
Indications:
Temporarily relieves the symptoms of infant gas, colic, upset stomach, bloating, hiccups.
Inactive Ingredients:
Citric Acid, Glycerin, Potassium Benzoate, Potassium Citrate, Potassium Sorbate, Purified Water, Xylitol.
Questions:
Distributed by: CVS Pharmacy, Inc.
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Package Label Display:
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)
* Please review the disclaimer below.
