4 Kids Cold n Cough Day and Night Combo Pack

Manufacturer
Hyland's | Standard Homeopathic Company | Applied Laboratories, Inc.
Effective date
2016-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:25:28

Label at a glance#

Product4 Kids Cold n Cough Day and Night Combo Pack
Active ingredientONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, SULFUR, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, STRYCHNOS NUX-VOMICA SEED
Label structure14 sections

Indications and uses

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

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 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)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DAYTIME

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of the common cold including nasal and chest congestion, runny nose, sore throat, sneezing and cough.

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.

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 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 up to 6 times per day (every 4 hours)
Children 6 years to under 12 years10 mL or 2 teaspoons up to 6 times per day (every 4 hours)
Adults and children 12 years and over15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

SPL UNCLASSIFIED SECTION

NIGHTTIME

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUSwatery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUSsensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUSoccasional sleeplessness, restlessness
Hepar Sulph Calc 12X HPUScold, sneezing
Hydrastis 6X HPUSrattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUSdry cough, sore throat
Nux Vomica 6X HPUS
(0.0000016% Alkaloids, calculated)
tired, difficulty falling asleep, frequent waking
Phosphorus 12X HPUShoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUSmoist cough, cold, nasal congestion
Sulphur 12X HPUSchest congestion, nasal congestion, sneezing, runny nose

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of the common cold including cough, runny nose, sneezing, nasal and chest congestion, and sore throat with accompanying 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.

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 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, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural Grape Flavor!

Natural
Relief

NDC 54973-3282-1
HOMEOPATHIC

Ages
2-12

SINCE 1903
Hyland's
4Kids
Cold 'n Cough*

Day & Night Combo Pack

DAYTIME

Nasal Congestion
Runny Nose
Sore Throat
Sneezing
Cough

Natural Grape
Flavor

ALCOHOL FREE
SUGAR FREE
DYE FREE

8 FL. OZ. (236 mL) Daytime

NIGHTTIME

Chest Congestion
Occasional Sleeplessness
Runny Nose
Sore Throat
Sneezing
Cough

Natural Grape
Flavor

ALCOHOL FREE
SUGAR FREE
DYE FREE

4 FL. OZ. (118 mL) Nighttime

12 FL. OZ. (354 mL) TOTAL

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54973-3243-1ML - Milliliter54973-32437d28e6b8-49a4-4b0d-a073-9caf269e10c612024-06-10

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-328254973-3282-1
54973-324354973-3243-2
54973-324554973-3245-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4 KIDS COLD N COUGH GRAPE FLAVORONION, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, AND SULFURHyland's Inc.798e2a4d-da2d-4bbd-a9b8-574490ef73572025-12-19WarningsExact identifier
ndc (package): 54973-3243-2
ndc (product): 54973-3243
ndc11 (package): 54973324302
edff0304-f22e-6dc6-e053-2995a90a56922af06fbf-df77-4bc7-bebe-a7460003308a2022-11-21WarningsExact identifier
spl set id: 2af06fbf-df77-4bc7-bebe-a7460003308a

Reported adverse events (FAERS/openFDA)#

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