Label: COLIC RELIEF- aloe, carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinale, mentha piperita, prunus spinosa, zingiber officinale liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 11, 2016

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  • 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.

  • 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.

    One CVS Drive, Woonsocket, RI 02895

    ©2015 CVS/Pharmacy

    CVS.com

    1-800-SHOP CVS

  • 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)

    Colic Relief label

    Colic Relief carton

  • INGREDIENTS AND APPEARANCE
    COLIC RELIEF 
    aloe, carbo vegetabilis, carum carvi, chamomilla, foeniculum vulgare, melissa officinale, mentha piperita, prunus spinosa, zingiber officinale liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-542
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE5 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL1 [hp_X]  in 1 mL
    CARAWAY SEED (UNII: W2FH8O2BBE) (CARAWAY SEED - UNII:W2FH8O2BBE) CARAWAY SEED5 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA5 [hp_X]  in 1 mL
    FENNEL SEED (UNII: G3QC02NIE6) (FENNEL SEED - UNII:G3QC02NIE6) FENNEL SEED5 [hp_X]  in 1 mL
    MELISSA OFFICINALIS (UNII: YF70189L0N) (MELISSA OFFICINALIS - UNII:YF70189L0N) MELISSA OFFICINALIS5 [hp_X]  in 1 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA5 [hp_X]  in 1 mL
    PRUNUS SPINOSA FLOWER BUD (UNII: 53Y84VPS2W) (PRUNUS SPINOSA FLOWER BUD - UNII:53Y84VPS2W) PRUNUS SPINOSA FLOWER BUD5 [hp_X]  in 1 mL
    GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ) GINGER5 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-542-011 in 1 CARTON
    159 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/10/2015
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(59779-542) , api manufacture(59779-542) , label(59779-542) , pack(59779-542)
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