Indications and uses
■ 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
4 Kids Cold and Cough Nighttime
- Manufacturer
- Hyland's Consumer Health Inc. | Hyland's Inc.
- Effective date
- 2025-02-06
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 11
- Source
- full-release
- Hydrated at
- 2026-06-01 02:31:48
Label at a glance#
Product4 Kids Cold and Cough Nighttime
Active ingredientONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, MATRICARIA CHAMOMILLA, GOLDENSEAL, ARABICA COFFEE BEAN, PHOSPHORUS, SULFUR
Label structure10 sections
Dosage and administration
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with dosing cup provides. ■ 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 ye...
Contacts and useful links#
Websitewww.hylands.com
www.hylands.com
www.hylands.comLabel contents#
Full prescribing information#
OTC - PURPOSE SECTION
Temporarily relieves symptoms of cough, runny nose, post nasal drip, sneezing, sore throat, nasal or chest congestion, and occasional sleeplessness.
Drug Facts
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” indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.
Uses*
■ 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
Sore throat warning
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
■ 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
■ 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
Ask a health professional before use.
Keep out of reach of children.
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.
■ Measure only with dosing cup provides. ■ 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
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions?
www.hylands.com or care@hylands.com
Indications and Usage "Uses"
Change to
- Temporarily relieves the symptoms of the common cold, including:
- cough
- runny nose
- post nasal drip
- sneezing
- nasal or chest congestion
- sore throat with accompanying occasional sleeplessness
Dosage and Administration "Directions"
Updates
- Shake well before using.
- Measure only with the dosing cup provided.
- Do not use dosing cup with other products.
- On dosing cup, mL = milliliter.
5 mL at bedtime and every
4 hours during the night
until relieved
10 mL at bedtime and every
4 hours during the night
until relieved
15 mL at bedtime and every
4 hours during the night
until relieved
PRINCIPAL DISPLAY PANEL - 4 FL. OZ. (118 mL) Carton
Hyland's
NATURALS™
•Kids•
Cold &
Cough*
NIGHTTIME
NO ALCOHOL, SUGAR,
PARABENS or DYES
Sleeplessness*
Congestion*
Runny Nose*
Sore Throat*
Cough*
Post Nasal
Drip*
2-12
YEARS
4 FL. OZ. (118 mL)
HOMEOPATHIC
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-3375-1 | 4 Kids Cold and Cough Nighttime | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 54973-3375-1 | 4 Kids Cold and Cough Nighttime | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 11 | |
| 54973-3375-2 | 4 Kids Cold and Cough Nighttime | 5 mL in 1 PACKET | LIQUID | 5 | 11 | |
| 54973-3375-3 | 4 Kids Cold and Cough Nighttime | 1 in 1 CARTON | LIQUID | 1 | 11 | |
| 54973-3375-3 | 4 Kids Cold and Cough Nighttime | 148 mL in 1 BOTTLE, PLASTIC | LIQUID | 148 | 11 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3375 | 4 KIDS COLD AND COUGH NIGHTTIME (ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS AND GOLDENSEAL) LIQUID [HYLAND'S CONSUMER HEALTH INC.] | 11 | Current NDC, Legacy NDC, 5 package rows | 20250209_71e93027-33c9-6147-e053-2a95a90aaa09.zip |
Products#
Every source-derived product name is available through these pages.
- 4 Kids Cold and Cough Nighttime
- ONION, CALCIUM SULFIDE, SODIUM CHLORIDE, ANEMONE PULSATILLA, ARABICA COFFEE BEAN, MATRICARIA CHAMOMILLA, SULFUR, PHOSPHORUS and GOLDENSEAL
- WATER
- GLYCYRRHIZA GLABRA
- GLYCERIN
- CITRIC ACID MONOHYDRATE
- SODIUM BENZOATE
- ONION
- CALCIUM SULFIDE
- SODIUM CHLORIDE
- CHLORIDE ION
- ANEMONE PULSATILLA
- MATRICARIA CHAMOMILLA
- GOLDENSEAL
- ARABICA COFFEE BEAN
- PHOSPHORUS
- SULFUR
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3375 | 54973-3375-1, 54973-3375-2, 54973-3375-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| WATER | 059QF0KO0R | IACT |
| GLYCYRRHIZA GLABRA | 2788Z9758H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| ONION | 492225Q21H | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 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 | 54973-3375-1 54973-3375-2 54973-3375-3 54973-3375 54973337501 54973337503 54973337502 2d83102a-9c33-5246-e063-6294a90ac8df 71e93027-33c9-6147-e053-2a95a90aaa09 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.