FDA.reportPublic FDA data

Kids Cold and Cough Combo Pack

Manufacturer
Hyland's Consumer Health Inc. | Hyland's Inc.
Effective date
2025-12-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:36:21

Label at a glance#

ProductKids Cold and Cough Combo Pack
Active ingredientCALCIUM SULFIDE, GOLDENSEAL, CHAMOMILE, SODIUM CHLORIDE, SULFUR, ARABICA COFFEE BEAN, PULSATILLA VULGARIS TOP, PHOSPHORUS, ONION, PULSATILLA VULGARIS WHOLE
Label structure5 sections

Indications and uses

Dyatime Uses* Nighttime Uses*

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Sleeplessness, Congestion, Runny Nose, Sore Throat, Cough, Post Nasal Drip

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION
Active ingredientsPurpose*
Allium Cepa 6X HPUS ............................... ...................................................watery/runny nose, cold, hacking cough, painful throat
Hepar Sulph Calc 12X HPUS.........................................................................cold, sneezing
Hydrastis 6X HPUS.......................................................................................rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS.......................................................................dry cough, sore throat
Phosphorus 12X HPUS ...............................................................................hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS .....................................................................................moist cough, cold, post nasal drip
Sulphur 12X HPUS.....................................................................................chest congestion, nasal congestion, sneezing, runny nose

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve symptoms of common cold in children, including:
■ runny nose ■ sore throat ■ sneezing ■ cough
■ post nasal drip ■ nasal or chest congestion

Warnings

WARNINGS SECTION

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 4 years
to under 6 years 		5 mL up to 6 times per day
(every 4 hours).
Children 6 years
to under 12 years 		10 mL up to 6 times per day
(every 4 hours).
Adults and children
12 years and over 		15 mL 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.

NIGHTTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION
Active ingredientsPurpose*
Allium Cepa 6X HPUS ....................................................................................watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS.....................................................................................occasional sleeplessness
Coffea Cruda 6X HPUS .................................................................................occasional sleeplessness
Hepar Sulph Calc 12X HPUS........................................................................cold, sneezing
Hydrastis 6X HPUS.......................................................................................rattling/tickling cough, sinus congestion, dry/raw/sore throat
Natrum Muriaticum 6X HPUS.......................................................................dry cough, sore throat
Phosphorus 12X HPUS .............................................................................. hoarse/dry cough, nasal congestion, chest congestion
Pulsatilla 6X HPUS ..................................................................................... moist cough, cold, post nasal drip
Sulphur 12X HPUS......................................................................................chest congestion, nasal congestion, sneezing, runny nose

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ cough ■ runny nose ■ post nasal drip ■ sneezing ■ sore throat
■ nasal or chest congestion ■ occasional sleeplessness

Warnings

WARNINGS SECTION

Sore throat warning

SPL UNCLASSIFIED SECTION

If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ persistent or chronic cough such as smoking, asthma, chronic bronchitis or emphysema. A persistent cough may be a sign of a serious condition. ■ cough that is accompanied by excessive phlegm (mucus).

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing cup provided. ■ Do not use
dosing cup with other products. ■ On dosing cup, mL = milliliter.

Children 4 years
to under 6 years 		5 mL at bedtime and every 4 hours
during the night until relieved.
Children 6 years
to under 12 years 		10 mL at bedtime and every 4 hours
during the night until relieved.
Adults and children
12 years and over 		15 mL at bedtime and every 4 hours
during the night until relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Indications and Usage

RECENT MAJOR CHANGES SECTION

Dyatime

Uses*

Nighttime

Uses*

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

Cold & Cough*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIMENIGHTTIME
Congestion*

Sleeplessness*

Runny Nose*Congestion*
Sore Throat*Runny Nose*
Cough*Sore Throat*
Post Nasal Drip*Cough*
Post Nasal Drip*

4 - 12 YEARS

NATURAL

GRAPE FLAVOR

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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362d7abb-94e6-4c60-9a58-266894157713Product name120231023
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e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4110-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4110-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL6 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Combo Pack118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL3
54973-4111-1Kids Cold and Cough Combo Pack1 in 1 CARTONLIQUID6 [hp_X] in 1mL3
54973-4112-1Kids Cold and Cough Combo Pack1 in 1 KITKIT13

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
54973-411254973-4112-1
54973-411154973-4111-1
54973-411054973-4110-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
CALCIUM SULFIDE1MBW07J51QACTIB
GOLDENSEALZW3Z11D0JVACTIB
CHAMOMILEFGL3685T2XACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
SULFUR70FD1KFU70ACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
PULSATILLA VULGARIS TOP4F1D271XW0ACTIB
PHOSPHORUS27YLU75U4WACTIB
ONION492225Q21HACTIB
GLYCYRRHIZA GLABRA2788Z9758HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
GOLDENSEALZW3Z11D0JVACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORUS27YLU75U4WACTIB
ONION492225Q21HACTIB
PULSATILLA VULGARIS WHOLEI76KB35JEVACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
SULFUR70FD1KFU70ACTIB

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
Kids Cold and Cough Combo PackONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e6ffd6d1-fcfb-547d-e053-2995a90af9b62025-12-19WarningsExact identifier
ndc (package): 54973-4111-1
ndc (package): 54973-4110-1
ndc (package): 54973-4112-1
ndc (product): 54973-4112
ndc11 (package): 54973411201
ndc11 (package): 54973411101
ndc11 (package): 54973411001
spl id: 4651df82-7583-1775-e063-6394a90a3e08
spl set id: e6ffd6d1-fcfb-547d-e053-2995a90af9b6
Kids Cold and Cough Nighttime Grape FlavorONION, CHAMOMILE, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS TOP, SULFURHyland's Consumer Health Inc.e676dbb7-212f-47e3-e053-2995a90af4e12022-08-17WarningsExact identifier
ndc (package): 54973-4111-1
ndc (product): 54973-4111
ndc11 (package): 54973411101
Kids Cold and Cough Daytime Grape FlavorONION, CALCIUM SULFIDE, GOLDEN SEAL, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS WHOLE, SULFURHyland's Consumer Health Inc.e65f14cb-5a8e-0ad5-e053-2a95a90a6f5d2022-08-16WarningsExact identifier
ndc (package): 54973-4110-1
ndc (product): 54973-4110
ndc11 (package): 54973411001

Reported adverse events (FAERS/openFDA)#

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