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#

Product4 Kids Cold and Mucus
Active ingredientMATRICARIA CHAMOMILLA, SODIUM CHLORIDE, SULFUR, RUMEX CRISPUS ROOT, ONION, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, GOLDENSEAL, PHOSPHORUS, ARABICA COFFEE BEAN, CALCIUM SULFIDE, SILICON DIOXIDE, ANEMONE PULSATILLA
Label structure4 sections

Label contents#

Full prescribing information#

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

INDICATIONS & USAGE SECTION

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

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.

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

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 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)

SPL UNCLASSIFIED SECTION

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 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

INACTIVE INGREDIENT SECTION

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

NIGHTTIME

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

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

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.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

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.

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 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

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT ACCEPTED

MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

KIT CARTONKIT CARTON

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-31794 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.]3Current NDC, Legacy NDC20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip
54973-33724 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.]3Current NDC, Legacy NDC20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip
54973-33814 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.]3Legacy NDC20221123_7276d1cd-faba-3d21-e053-2a91aa0a5f9a.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-338154973-3381-1
54973-337254973-3372-2
54973-317954973-3179-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46510730-05f9-13bb-e063-6394a90af2077276d1cd-faba-3d21-e053-2a91aa0a5f9a2025-12-19WarningsExact identifier
spl set id: 7276d1cd-faba-3d21-e053-2a91aa0a5f9a
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): 54973-3372-2
ndc (product): 54973-3372
ndc11 (package): 54973337202
4 Kids Complete Cold and MucusBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.ef39fe3d-a42d-4baa-9199-91f664feb4322022-11-21WarningsExact identifier
ndc (package): 54973-3179-1
ndc (product): 54973-3179
ndc11 (package): 54973317901

Reported adverse events (FAERS/openFDA)#

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