4 Kids Cold and Cough Daytime and Nighttime

Manufacturer: Hyland’s Inc. | Hyland's Inc.
Effective date: 2023-09-27
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 21:25:34

Label at a glance#

Product4 Kids Cold and Cough Daytime and Nighttime

Active ingredientSODIUM CHLORIDE, ONION, CALCIUM SULFIDE, PHOSPHORUS, SULFUR, GOLDENSEAL, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA

Label structure5 sections

Indications and uses

Uses*

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

DAYTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose*
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 2 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, Purified Water, Sodium Benzoate.

NIGHTTIME

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose*
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

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 2 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, Purified Water, Sodium Benzoate.

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

OTC - PURPOSE 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.

Indications and Usage

RECENT MAJOR CHANGES SECTION

Uses*

Principal Display Panel - Kids Cold & Cough Daytime Nighttime Combo Pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•baby•

Cold & Cough*

COMBO BACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

NIGHTTIME

Sleeplessness*

Congestion*

Runny Nose*

Sore Throat*

Cough*

Post Nasal

Drip*

2 - 12 YEARS

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

HOMEOPATHIC

carton

Products#

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

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

4 Kids Cold and Cough Daytime and Nighttime
onion, calcium sulfide, sodium chloride, anemone pulsatilla, arabica coffee bean, matricaria chamomilla, sulfur, phosphorus and goldenseal
COLD AND COUGH 4 KIDS
onion, calcium sulfide, sodium chloride, phosphorus, pulsatilla vulgaris, sulfur, and goldenseal
WATER
GLYCERIN
CITRIC ACID MONOHYDRATE
SODIUM BENZOATE
GLYCYRRHIZA GLABRA
SODIUM CHLORIDE
SODIUM CATION
ONION
CALCIUM SULFIDE
PHOSPHORUS
SULFUR
GOLDENSEAL
ANEMONE PULSATILLA
4 KIDS COLD AND COUGH NIGHTTIME
ARABICA COFFEE BEAN
CHLORIDE ION
MATRICARIA CHAMOMILLA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-3378	54973-3378-1
54973-3075	54973-3075-1
54973-3375	54973-3375-1

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
Name	UNII	Kind
WATER	059QF0KO0R	IACT
GLYCERIN	PDC6A3C0OX	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
SODIUM CHLORIDE	451W47IQ8X	ACTIB
ONION	492225Q21H	ACTIB
CALCIUM SULFIDE	1MBW07J51Q	ACTIB
PHOSPHORUS	27YLU75U4W	ACTIB
SULFUR	70FD1KFU70	ACTIB
GOLDENSEAL	ZW3Z11D0JV	ACTIB
ANEMONE PULSATILLA	I76KB35JEV	ACTIB
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
GLYCERIN	PDC6A3C0OX	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
WATER	059QF0KO0R	IACT
ARABICA COFFEE BEAN	3SW678MX72	ACTIB
ONION	492225Q21H	ACTIB
CALCIUM SULFIDE	1MBW07J51Q	ACTIB
PHOSPHORUS	27YLU75U4W	ACTIB
SODIUM CHLORIDE	451W47IQ8X	ACTIB
ANEMONE PULSATILLA	I76KB35JEV	ACTIB
MATRICARIA CHAMOMILLA	G0R4UBI2ZZ	ACTIB
GOLDENSEAL	ZW3Z11D0JV	ACTIB
SULFUR	70FD1KFU70	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
4650f589-b338-2303-e063-6294a90af6e7			754e8087-d825-4328-e053-2991aa0a152f	2025-12-19	Warnings	Exact identifier spl set id: 754e8087-d825-4328-e053-2991aa0a152f
Cold and Cough 4 Kids	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, PULSATILLA VULGARIS, SULFUR, AND GOLDENSEAL	Hyland's Inc.	e06599ca-fc94-4b2c-829e-f3d4ec866ed6	2025-10-29	Warnings	Exact identifier ndc (package): 54973-3075-1 ndc (product): 54973-3075 ndc11 (package): 54973307501
4 Kids Cold and Cough Nighttime	ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL	Hyland's Consumer Health Inc.	71e93027-33c9-6147-e053-2a95a90aaa09	2025-02-06	Warnings	Exact identifier ndc (package): 54973-3375-1 ndc (product): 54973-3375 ndc11 (package): 54973337501

Reported adverse events (FAERS/openFDA)#

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