4Kids Cold N Mucus Nighttime

Manufacturer
Hyland's | Standard Homeopathic Company | Applied Laboratories, Inc. | LGM Pharma Solutions, LLC
Effective date
2021-05-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:42:51

Label at a glance#

Product4Kids Cold N Mucus Nighttime
Active ingredientONION, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, EUPHRASIA STRICTA, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SULFUR
Label structure9 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#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
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 HPUS
(0.0000016% Alkaloids, calculated)
tired, difficulty falling asleep, 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, sneezing
Silicea 12X HPUSnasal congestion
Sulphur 12X HPUScough with thick mucus, chest congestion, nasal congestion

"HPUS" indicates 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. 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

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.

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

Sore throat warning

SPL UNCLASSIFIED SECTION

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 preprinted tamper band is broken or missing.

SPL UNCLASSIFIED SECTION

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 years5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary
Children 6 years to under 12 years10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary
Adults and children 12 years and over15 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

OTC - PURPOSE 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.

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3250-1

HOMEOPATHIC

Natural

Relief

Ages

2-12

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

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

cartoncarton

Products#

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DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-325054973-3250-1, 54973-3250-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 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
d39debe3-16c4-14db-e053-2995a90a53caa27c429b-afdb-4fef-b91c-3fbd35557d6f2021-12-20WarningsExact identifier
spl set id: a27c429b-afdb-4fef-b91c-3fbd35557d6f

Reported adverse events (FAERS/openFDA)#

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