Label: 4 KIDS COLD AND MUCUS- euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur kit
- NDC Code(s): 54973-3179-1, 54973-3372-2, 54973-3381-1
- Packager: Hyland's Inc.
- 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 November 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
DAYTIME
Drug Facts
Active ingredients
Bryonia Alba 6X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Natrum Muriaticum 30X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUS...cough with mucus in chest
Hepar Sulph Calc 12X HPUS......cough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUS.....accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS.................runny nose, sneezing
Silicea 12X HPUS...................................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 and nasal congestion.
Warnings
Consult a physician if:
- symptoms persist for more than 7 days or worsen.
- inflammation, fever or infection develops.
- symptoms are accompanied by a high fever (over 101°F).
- cough tends to recur or is accompanied by a 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 or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
Drug Facts (continued)
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
Children 2 years
to under 6 years
5 mL or 1 teaspoon up to
6 times per day (every 4 hours)
Children 6 years
to under 12 years
10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
Adults and children
12 years and over
15 mL or 3 teaspoons up to 6 times per day (every 4 hours)
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NIGHTTIME
Active ingredients
Allium Cepa 6X HPUS
Bryonia Alba 6X HPUS
Chamomilla 3X HPUS
Coffea Cruda 3X HPUS
Euphrasia Officinalis 6X HPUS
Hepar Sulph Calc 12X HPUS
Hydrastis 6X HPUS
Natrum Muriaticum 6X HPUS
Phosphorus 30X HPUS
Pulsatilla 6X HPUS
Rumex Crispus 6X HPUS
Silicea 12X HPUS
Sulphur 12X HPUS
“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUS..................runny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUS...stubborn mucus in throat, cough with yellowish mucus
Chamomilla 3X HPUS.....irritability, fussiness, occasional sleeplessness
Coffea Cruda 3X HPUS.............occasional sleeplessness, restlessness
Euphrasia Officinalis 6X HPUS...cough with mucus in chest
Hepar Sulph Calc 12X HPUS......cough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUS...cough with mucus, dry, sore throat, occasional sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUS...accumulation of mucus in throat, cough up mucus
Phosphorus 30X HPUS.........cough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUS...accumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUS.................runny nose, sneezing
Silicea 12X HPUS...................................nasal congestion
Sulphur 12X HPUS............cough with thick mucus, chest congestion, nasal congestion
Uses
Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.
Drug Facts (continued)
Warnings
Consult a physician if:
- symptoms persist for more than 7 days or worsen.
- inflammation, fever or infection develops.
- symptoms are accompanied by a high fever (over 101°F).
- cough tends to recur or is accompanied by a 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 or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.
Directions
- Measure only with the dosing cup provided
- Do not use dosing cup with other products
- On dosing cup, mL = milliliter, tsp = teaspoon
Children 2 years
to under 6 years
5 mL or 1 teaspoon at bedtime
and every 4 hours during the
night or as necessary
Children 6 years
to under 12 years
10 mL or 2 teaspoons at bedtime and every 4 hours
during the night or as necessary
Adults and children
12 years and over
15 mL or 3 teaspoons at bedtime and every 4 hours
during the night or as necessary
- SPL UNCLASSIFIED SECTION
-
Principal Display Panel - Kit Carton
NDC 54973-3381-1
HOMEOPATHIC
Ages
2-12
NATURAL
RELIEF
SINCE 1903
Hyland's
4 Kids
Cold'n Mucus*
Loosens mucus in chest, throat and nose
Day & Night Value Pack
DAYTIME
Mucus & Congestion
Runny Nose
Cough
ALCOHOL FREE
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Daytime
NIGHTTIME
Mucus & Congestion
Occasional Sleeplessness
Runny Nose
Cough
LESS THAN 0.2% ALCOHOL
SUGAR FREE
DYE FREE
4 FL. OZ. (118 mL) Nighttime
8 FL. OZ. (236 mL) TOTAL
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INGREDIENTS AND APPEARANCE
4 KIDS COLD AND MUCUS
euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54973-3381 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3381-1 1 in 1 CARTON 08/01/2018 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 118 mL Part 2 1 BOTTLE, PLASTIC 118 mL Part 1 of 2 4 KIDS COLD AND MUCUS NIGHTTIME
euphrasia stricta,silicon dioxide, rumex crispus root, anemone pulsatilla, goldenseal, sodium chloride, phosphorus, onion, bryonia alba root, matricaria chamomilla, arabica coffee bean, calcium sulfide and sulfur liquidProduct Information Item Code (Source) NDC:54973-3372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ) MATRICARIA CHAMOMILLA 3 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 6 [hp_X] in 1 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 12 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H) ONION 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL 6 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL ARABICA COFFEE BEAN (UNII: 3SW678MX72) (ARABICA COFFEE BEAN - UNII:3SW678MX72) ARABICA COFFEE BEAN 3 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3372-2 1 in 1 CARTON 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 06/27/2018 Part 2 of 2 4 KIDS COMPLETE COLD AND MUCUS
bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide liquidProduct Information Item Code (Source) NDC:54973-3179 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA 6 [hp_X] in 1 mL BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT 6 [hp_X] in 1 mL ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV) ANEMONE PULSATILLA 6 [hp_X] in 1 mL SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 30 [hp_X] in 1 mL PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS 30 [hp_X] in 1 mL SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE 12 [hp_X] in 1 mL RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT 6 [hp_X] in 1 mL CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE 12 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54973-3179-1 1 in 1 CARTON 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 07/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2018 Labeler - Hyland's Inc. (008316655) Establishment Name Address ID/FEI Business Operations LGM Pharma Solutions, LLC 117549198 manufacture(54973-3381) , pack(54973-3381) , label(54973-3381) Establishment Name Address ID/FEI Business Operations Applied Laboratories, Inc. 117337220 manufacture(54973-3381) , pack(54973-3381) , label(54973-3381)