BABY MUCUS COLD RELIEF DAY AND NIGHT VALUE PACK (BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE, O

BABY MUCUS COLD RELIEF DAY AND NIGHT VALUE PACK (BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE, O
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NDC 54973-3251-1, 54973-3284-1, 54973-3313-1
Set ID 45eb3326-1310-4044-997c-42c4abc6789d
Category HUMAN OTC DRUG LABEL
Packager Hyland's
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    DAYTIME

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Bryonia Alba 6X HPUSstubborn mucus in throat, cough with yellowish mucus
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
    Phosphorus 30X HPUScough with expectoration of yellow mucus, chest congestion
    Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
    Rumex Crispus 6X HPUSrunny nose, sneezing
    Silicea 12X HPUSnasal congestion
  • Uses

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

  • Warnings

    As with any drug ask a doctor before use if pregnant or breast-feeding. Consult a physician if:

    • Symptoms persist for more than 7 days or worsen
    • Inflammation, fever or infection develops
    • Symptoms are accompanied by high fever (101°F)
    • Cough tends to recur or is accompanied by high fever, rash or persistent headache.

    Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately.

    Do not use this product for persistent or chronic cough such as asthma, smoking, emphysema or 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. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

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

    In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • 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 ageconsult a licensed health care professional before using this product
    Children 6 months to under 1 year of age2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
    Children 1 to 3 years of age5 mL or 1 teaspoon up to 6 times daily (every 4 hours)
  • Inactive ingredients

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

  • SPL UNCLASSIFIED SECTION

    NIGHTTIME

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    "HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
    Allium Cepa 6X HPUSrunny nose with mucus, hacking cough, sore throat
    Bryonia Alba 6X HPUSstubborn mucus in throat, cough with yellowish mucus
    Chamomilla 3X HPUSirritability, fussiness, occasional sleeplessness
    Coffea Cruda 3X HPUSoccasional sleeplessness, restlessness
    Euphrasia Officinalis 6X HPUScough with mucus in chest
    Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
    Hydrastis 6X HPUScough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
    Natrum Muriaticum 6X HPUSaccumulation of mucus in throat, cough up mucus
    Nux Vomica 6X HPUStired, difficulty falling asleep, (0.0000016% Alkaloids, calculated) frequent waking
    Phosphorus 30X HPUScough with expectoration of yellow mucus, chest congestion
    Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
    Rumex Crispus 6X HPUSrunny nose and sneezing
    Silicea 12X HPUSnasal congestion
    Sulphur 12X HPUScough with thick mucus, chest congestion, nasal congestion
  • Uses

    Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing, nasal congestion; and irritability, fussiness and occasional sleeplessness.

  • Warnings

    Consult a physician if:

    • Symptoms persist for more than 7 days or worsen
    • Inflammation, fever or infection develops
    • Symptoms are accompanied by high fever (101°F)
    • Cough tends to recur or is accompanied by high fever, rash or persistent headache

    Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center immediately.

    Do not use this product for persistent or chronic cough such as asthma, smoking, emphysema or 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. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

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

    In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

  • 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 ageconsult a licensed health care professional before using this product
    Children 6 months to under 1 year of age2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
    Children 1 to 3 years of age5 mL or 1 teaspoon up to 6 times daily (every 4 hours)
  • Inactive ingredients

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

  • Questions or comments?

    (800) 624-9659

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    New!

    NDC 54973-3313-1
    HOMEOPATHIC

    Ages 6 months+

    SINCE 1903
    Hyland's®
    Baby

    Natural
    Relief

    Day & Night Value Pack

    Daytime

    Mucus +
    Cold Relief

    LOOSENS MUCUS,
    RELIEF OF
    CONGESTION,
    RUNNY NOSE
    AND COUGH*

    ALCOHOL FREE

    4 FL. OZ. (118 mL) Daytime

    Nighttime

    Mucus +
    Cold Relief

    LOOSENS MUCUS,
    RELIEF OF
    CONGESTION,
    AND
    OCCASIONAL
    SLEEPLESSNESS
    DUE TO COLDS*

    LESS THAN 0.2% ALCOHOL

    4 FL. OZ. (118 mL) Nighttime

    ▶ No Artificial Flavors, Dyes or Parabens

    8 FL. OZ. (236 mL) TOTAL

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    BABY MUCUS COLD RELIEF DAY AND NIGHT VALUE PACK 
    bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, silicon dioxide, onion, matricaria recutita, arabica coffee bean, goldenseal, strychnos nux-vomica seed, and sulfur kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54973-3313
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3313-11 in 1 CARTON03/30/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 118 mL
    Part 21 BOTTLE, PLASTIC 118 mL
    Part 1 of 2
    BABY MUCUS AND COLD RELIEF 
    bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquid
    Product Information
    Item Code (Source)NDC:54973-3284
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE30 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3284-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic05/13/2016
    Part 2 of 2
    BABY NIGHTTIME MUCUS COLD RELIEF 
    onion, bryonia alba root, matricaria recutita, arabica coffee bean, euphrasia stricta, calcium sulfide, goldenseal, sodium chloride, strychnos nux-vomica seed, phosphorus, pulsatilla vulgaris, rumex crispus root, silicon dioxide, and sulfur liquid
    Product Information
    Item Code (Source)NDC:54973-3251
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION6 [hp_X]  in 1 mL
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT6 [hp_X]  in 1 mL
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
    ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN3 [hp_X]  in 1 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 1 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 1 mL
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL6 [hp_X]  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6 [hp_X]  in 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 1 mL
    PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
    ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA6 [hp_X]  in 1 mL
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT6 [hp_X]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR12 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LICORICE (UNII: 61ZBX54883)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54973-3251-1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic12/28/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic03/30/2017
    Labeler - Hyland's (028570695)
    Establishment
    NameAddressID/FEIBusiness Operations
    Standard Homeopathic Company008316655MANUFACTURE(54973-3313, 54973-3284, 54973-3251) , PACK(54973-3313, 54973-3284, 54973-3251) , LABEL(54973-3313, 54973-3284, 54973-3251)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEXGEN PHARMA, INC.079424083MANUFACTURE(54973-3313, 54973-3284, 54973-3251) , PACK(54973-3313, 54973-3284, 54973-3251)
    Establishment
    NameAddressID/FEIBusiness Operations
    Applied Laboratories, Inc.117337220PACK(54973-3313, 54973-3284, 54973-3251)

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