4 Kids Cold and Mucus
- Manufacturer
- Hyland's Inc. | LGM Pharma Solutions, LLC | Applied Laboratories, Inc.
- Effective date
- 2022-11-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:18:36
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
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.
OTC - PURPOSE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, ask a doctor before use if pregnant or breast-feeding.
OTC - ASK DOCTOR SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
OTC - DO NOT USE SECTION
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.
SPL UNCLASSIFIED SECTION
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.
OTC - DO NOT USE SECTION
Do not use if imprinted tamper-evident bottle band is broken or missing.
SPL UNCLASSIFIED SECTION
The inner packaged bottle is child-resistant. 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.
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) |
Inactive ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
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.
OTC - PURPOSE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
As with any drug, ask a doctor before use if pregnant or breast-feeding.
OTC - ASK DOCTOR SECTION
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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.
SPL UNCLASSIFIED SECTION
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.
SPL UNCLASSIFIED SECTION
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.
OTC - DO NOT USE SECTION
Do not use if imprinted tamper-evident bottle band is broken or missing.
SPL UNCLASSIFIED SECTION
The inner packaged bottle is child-resistant. 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 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 |
Inactive ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions or comments?
(800) 624-9659
SPL UNCLASSIFIED SECTION
*CLAIMS BASED ON TRADITIONAL
HOMEOPATHIC PRACTICE, NOT ACCEPTED
MEDICAL EVIDENCE. NOT FDA EVALUATED.
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
DailyMed Product Concepts#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3179 | 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 [HYLAND'S INC.] | 3 | Current NDC, Legacy NDC | 20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip |
| 54973-3372 | 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 [HYLAND'S INC.] | 3 | Current NDC, Legacy NDC | 20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip |
| 54973-3381 | 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 [HYLAND'S INC.] | 3 | Legacy NDC | 20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip |
Products#
Every source-derived product name is available through these pages.
- 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
- 4 KIDS COLD AND MUCUS NIGHTTIME
- GLYCYRRHIZA GLABRA
- SODIUM BENZOATE
- WATER
- CITRIC ACID MONOHYDRATE
- GLYCERIN
- MATRICARIA CHAMOMILLA
- SODIUM CHLORIDE
- CHLORIDE ION
- SULFUR
- RUMEX CRISPUS ROOT
- ONION
- BRYONIA ALBA ROOT
- EUPHRASIA STRICTA
- GOLDENSEAL
- PHOSPHORUS
- ARABICA COFFEE BEAN
- CALCIUM SULFIDE
- SILICON DIOXIDE
- ANEMONE PULSATILLA
- 4 KIDS COMPLETE COLD AND MUCUS
- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3381 | 54973-3381-1 |
| 54973-3372 | 54973-3372-2 |
| 54973-3179 | 54973-3179-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 46510730-05f9-13bb-e063-6394a90af207 | 7276d1cd-faba-3d21-e053-2a91aa0a5f9a | 2025-12-19 | Warnings | 7276d1cd-faba-3d21-e053-2a91aa0a5f9a | ||
| 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 | Hyland's Inc. | 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1 | 2022-11-21 | Warnings | 54973-3372-2 54973-3372 54973337202 |
| 4 Kids Complete Cold and Mucus | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | ef39fe3d-a42d-4baa-9199-91f664feb432 | 2022-11-21 | Warnings | 54973-3179-1 54973-3179 54973317901 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
