Label: CVS BABY NIGHTTIME COLD AND COUGH- matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide 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 10, 2017

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

    Active ingredients Purpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Chamomilla 6X HPUS occasional sleeplessness
    Eupatorium Perfoliatum 6X HPUS headache, cough, sneezing
    Euphrasia Officinalis 6X HPUS runny eyes and nose
    Gelsemium Sempervirens 6X HPUS sneezing with stuffy nose
    Kali Iodatum 6X HPUS headache, runny eyes and nose
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  • Uses

    Temporarily relieves the symptoms of runny nose and eyes, cough, congestion, headache, sneezing and occasional sleeplessness due to common head colds in children.

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  • Warnings

    Do not use

    • for persistent or chronic cough such as occurs with asthma, smoking or emphysema
    • if cough is accompanied by excessive mucus, unless directed by a licensed health care professional

    A persistent cough may be a sign of a serious condition.

    Stop use and ask a doctor if

    • symptoms persist for more than 7 days or worsen
    • symptoms are accompanied by high fever (101°F)
    • cough tends to recur or is accompanied by high fever, rash or persistent headache

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

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  • Directions

    • Measure only with the dosing syringe provided
    • Do not use dosing syringe with other products
    • On dosing syringe, mL = milliliter, tsp = teaspoon
    children under 6 months of age consult a licensed health care professional before using this product
    children 6 months to under 1 year of age 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
    children 1 to 3 years of age 5 mL or 1 teaspoon up to 6 times daily (every 4 hours)
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  • Other information

    Do not use if imprinted tamper band is broken or missing.

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  • Inactive ingredients

    Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    CVS Pharmacy, Inc.

    One CVS Drive
    Woonsocket, RI 02895

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    ♥CVS
    Health

    Compare to the active
    ingredients of Hyland's®
    Baby Nighttime Tiny
    Cold Syrup

    NDC 69842-411-01

    Homeopathic
    Baby
    Nighttime
    Cold & Cough*

    CHAMOMILLA 6X HPUS
    Occasional sleeplessness

    EUPATORIUM PERFOLIATUM 6X HPUS
    Headache, cough, sneezing

    EUPHRASIA OFFICINALIS 6X HPUS
    Runny eyes and nose

    GELSEMIUM SEMPERVIRENS 6X HPUS
    Sneezing with stuffy nose

    KALI IODATUM 6X HPUS
    Headache, runny eyes and nose

    Relief Of:
    Runny nose, congestion and
    occasional sleeplessness
    due to colds

    Alcohol Free
    No Artificial Flavors,
    Dyes or Parabens

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    CVS BABY NIGHTTIME COLD AND COUGH 
    matricaria recutita, eupatorium perfoliatum flowering top, euphrasia stricta, gelsemium sempervirens root, and potassium iodide liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:69842-411
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA 6 [hp_X]  in 1 mL
    EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E) EUPATORIUM PERFOLIATUM FLOWERING TOP 6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X]  in 1 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 6 [hp_X]  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) POTASSIUM IODIDE 6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:69842-411-01 1 in 1 CARTON 02/10/2017
    1 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 02/10/2017
    Labeler - CVS Pharmacy (062312574)
    Establishment
    Name Address ID/FEI Business Operations
    Standard Homeopathic Company 008316655 MANUFACTURE(69842-411) , PACK(69842-411) , LABEL(69842-411)
    Establishment
    Name Address ID/FEI Business Operations
    NEXGEN PHARMA, INC. 079424083 MANUFACTURE(69842-411) , PACK(69842-411)
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