4 Kids Cold and Mucus Nighttime

Manufacturer
Hyland's Inc. | LGM Pharma Solutions, LLC | Applied Laboratories, Inc.
Effective date
2022-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:18:36

Label at a glance#

Product4 Kids Cold and Mucus Nighttime
Active ingredientONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, EUPHRASIA STRICTA, GOLDENSEAL, SODIUM CHLORIDE, SULFUR, ARABICA COFFEE BEAN, CALCIUM SULFIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE
Label structure8 sections

Indications and 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.

Dosage and administration

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 teas...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

Purpose

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

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

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.

Warnings

WARNINGS SECTION

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.

SPL UNCLASSIFIED SECTION

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.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRIMARY PRINCIPAL DISPLAY - 4 FL. OZ. (118 mL) BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3372-2

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4KIDS

Cold'n

Mucus

NIGHTTIME

Loosens mucus in

chest, throat and nose

Mucus & Congestion

Occasional Sleeplessness

Runny Nose

Cough

LESS THAN 0.2%ALCOHOL

SUGAR FREE

DYE FREE

4 FL. OZ. (118 mL)

carton1carton1

carton2carton2

DailyMed Product Concepts#

Product concept, Relation, Version table
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3372-14 Kids Cold and Mucus Nighttime1 in 1 CARTONLIQUID16
54973-3372-14 Kids Cold and Mucus Nighttime148 mL in 1 BOTTLE, PLASTICLIQUID1486
54973-3372-24 Kids Cold and Mucus Nighttime1 in 1 CARTONLIQUID16
54973-3372-24 Kids Cold and Mucus Nighttime118 mL in 1 BOTTLE, PLASTICLIQUID1186
54973-3372-34 Kids Cold and Mucus Nighttime5 mL in 1 PACKETLIQUID56

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-33724 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) LIQUID [HYLAND'S INC.]6Current NDC, Legacy NDC, 5 package rows20221122_6f7b2585-2f0e-5938-e053-2a91aa0aa9d1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-337254973-3372-2, 54973-3372-1, 54973-3372-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 Kids Cold and Mucus NighttimeEUPHRASIA STRICTA,SILICON DIOXIDE, RUMEX CRISPUS ROOT, ANEMONE PULSATILLA, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ONION, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE AND SULFURHyland's Inc.6f7b2585-2f0e-5938-e053-2a91aa0aa9d12022-11-21WarningsExact identifier
ndc (package): 54973-3372-1
ndc (package): 54973-3372-2
ndc (package): 54973-3372-3
ndc (product): 54973-3372
ndc11 (package): 54973337203
ndc11 (package): 54973337201
ndc11 (package): 54973337202
spl id: edfdffd2-0080-6d36-e053-2a95a90aa818
spl set id: 6f7b2585-2f0e-5938-e053-2a91aa0aa9d1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.