Indications and uses
Temporarily relieves symptoms of common cold in children especially at night, including: cough runny nose post nasal drip sneezing nasal or chest congestion sore throat with accompanying occasional sleeplessness
4 Kids Cold and Cough Nighttime Natural Grape Flavor
- Manufacturer
- Hyland's Inc.
- Effective date
- 2025-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 13
- Source
- full-release
- Hydrated at
- 2026-06-01 02:36:19
Label at a glance#
Product4 Kids Cold and Cough Nighttime Natural Grape Flavor
Active ingredientSODIUM CHLORIDE, ONION, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, CALCIUM SULFIDE, GOLDENSEAL, PHOSPHORUS, ANEMONE PULSATILLA, SULFUR
Label structure13 sections
Dosage and administration
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 1...
Contacts and useful links#
Websitewww.hylands.com
www.hylands.com
www.hylands.comLabel contents#
Full prescribing information#
OTC - PURPOSE SECTION
Relieves congestion, runny nose, sore throat, sneezing, cough, post nasal drip and occasional sleeplessness
Drug Facts
Active ingredients
Allium Cepa 6X HPUS ..........watery/runny nose, cold, hacking cough, painful throat
Chamomilla 6X HPUS ......... sensitive, irritable, fussy, nocturnal occasional sleeplessness
Coffea Cruda 6X HPUS........occasional sleeplessness, restlessness
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
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.
OTC - ASK DOCTOR SECTION
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).
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breastfeeding,ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
Directions
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
Citric Acid, Glycerine, Glycyrrhiza Extract,Natural Grape Flavor Purified Water, Sodium Benzoate.
Questions?
www.hylands.com or care@hylands.com
SPL UNCLASSIFIED SECTION
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
OTHER SAFETY INFORMATION
DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.
Indications and Usage
Temporarily relieves symptoms of common cold in children especially at night, including:
cough
runny nose
post nasal drip
sneezing
nasal or chest congestion
sore throat with accompanying occasional sleeplessness
Dosage and Administration
Directions
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 6 years
to under 12 years
Adults and children
12 years and over
Children 2 years
to under 6 years
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
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
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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
NATURAL
GRAPE FLAVOR
4 FL. OZ. (118 mL)
HOMEOPATHIC
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 54973-3377-3 5 FL. OZ. (148 mL)
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-3377-1 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 1 in 1 CARTON | LIQUID | 1 | 13 | |
| 54973-3377-1 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 | 13 | |
| 54973-3377-2 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 5 mL in 1 PACKET | LIQUID | 5 | 13 | |
| 54973-3377-3 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 148 mL in 1 BOTTLE, PLASTIC | LIQUID | 148 | 13 | |
| 54973-3377-3 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 1 in 1 CARTON | LIQUID | 1 | 13 | |
| 54973-3377-4 | 4 Kids Cold and Cough Nighttime Natural Grape Flavor | 5 mL in 1 POUCH | LIQUID | 5 | 13 |
Products#
Every source-derived product name is available through these pages.
- 4 Kids Cold and Cough Nighttime Natural Grape Flavor
- onion,anemone pulsatilla, phosphorus, goldenseal, calcium sulfide, sodium chloride, sulfur, matricaria chamomilla and arabica coffee bean
- CITRIC ACID MONOHYDRATE
- GLYCYRRHIZA GLABRA
- GLYCERIN
- WATER
- SODIUM BENZOATE
- SODIUM CHLORIDE
- CHLORIDE ION
- ONION
- MATRICARIA CHAMOMILLA
- ARABICA COFFEE BEAN
- CALCIUM SULFIDE
- GOLDENSEAL
- PHOSPHORUS
- ANEMONE PULSATILLA
- SULFUR
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3377 | 54973-3377-1, 54973-3377-2, 54973-3377-3, 54973-3377-4 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CITRIC ACID MONOHYDRATE | 2968PHW8QP | IACT |
| GLYCYRRHIZA GLABRA | 2788Z9758H | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM CHLORIDE | 451W47IQ8X | ACTIB |
| ONION | 492225Q21H | ACTIB |
| MATRICARIA CHAMOMILLA | G0R4UBI2ZZ | ACTIB |
| ARABICA COFFEE BEAN | 3SW678MX72 | ACTIB |
| CALCIUM SULFIDE | 1MBW07J51Q | ACTIB |
| GOLDENSEAL | ZW3Z11D0JV | ACTIB |
| PHOSPHORUS | 27YLU75U4W | ACTIB |
| ANEMONE PULSATILLA | I76KB35JEV | ACTIB |
| SULFUR | 70FD1KFU70 | ACTIB |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 12 | 2025-10-29 | monthly-update | 2026-06-03 17:37:48 |
| 10 | 2023-06-22 | full-release | 2026-06-01 02:21:29 |
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 Natural Grape Flavor | ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN | Hyland's Inc. | 7923e59a-f62c-44df-e053-2991aa0afc1e | 2025-12-19 | Warnings | 54973-3377-2 54973-3377-3 54973-3377-4 54973-3377-1 54973-3377 54973337701 54973337702 54973337704 54973337703 4651b75f-03ba-f16a-e063-6394a90aec70 7923e59a-f62c-44df-e053-2991aa0afc1e |
| 4 Kids Cold and Cough Day and Night Grape Flavor | ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN | Hyland's Inc. | 79f26bb5-15ad-e40a-e053-2991aa0aaab3 | 2025-12-19 | Warnings | 54973-3377-1 54973337701 |
| 4 Kids Cold and Cough Day and Night Grape Flavor | ONION,ANEMONE PULSATILLA, PHOSPHORUS, GOLDENSEAL, CALCIUM SULFIDE, SODIUM CHLORIDE, SULFUR, MATRICARIA CHAMOMILLA AND ARABICA COFFEE BEAN | Hyland's Inc. | 1a297e56-4cb8-75ca-e063-6294a90a592b | 2025-02-20 | Warnings | 54973-3377-1 54973337701 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.