Indications and uses
Added asterisk (*) to Uses for Daytime and Nighttime
BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME
- Manufacturer
- Hyland's Inc.
- Effective date
- 2023-08-23
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- full-release
- Hydrated at
- 2026-06-01 02:22:11
Label at a glance#
ProductBABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME
Active ingredientANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ONION, MATRICARIA CHAMOMILLA, SULFUR, ARABICA COFFEE BEAN, GOLDENSEAL
Label structure7 sections
Contacts and useful links#
Websitewww.hylands.com
www.hylands.com
www.hylands.comLabel contents#
Full prescribing information#
DAYTIME
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
| Active ingredients | Purpose* |
| Bryonia Alba 6X HPUS | stubborn mucus in throat, cough with mucus |
| Euphrasia Officinalis 6X HPUS | cough with mucus in chest |
| Hepar Sulph Calc 12X HPUS | cough up mucus, mucus rattle with cough, stubborn mucus in chest |
| Natrum Muriaticum 30X HPUS | accumulation of mucus in throat, cough up mucus |
| Phosphorus 30X HPUS | cough with mucus, chest congestion |
| Pulsatilla 6X HPUS | accumulation of mucus, discharge of mucus, loose cough |
| Rumex Crispus 6X HPUS | runny nose, sneezing |
| Silicea 12X HPUS | nasal congestion |
HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing
■ nasal or chest congestion
Warnings
Ask a doctor before use if you have
■ persistent or chronic cough such as 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 72 hours or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.
Keep out of reach of children
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.
■ Measure only with the dosing syringe provided. ■ Do not use dosing
syringe with other products. ■ On dosing syringe, mL = milliliter.
| Children under
6 months | Ask a doctor before use. |
| Children 6 months
to under 1 year | 2.5 mL up to 4 times per day
(every 6 hours). |
| Children 1 year
to under 3 years | 5 mL up to 6 times per day
(every 4 hours). |
Inactive ingredients
Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
NIGHTTIME
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
| Active ingredients | Purpose* |
| Allium Cepa 6X HPUS | runny nose with mucus, hacking cough, sore throat |
| Bryonia Alba 6X HPUS | stubborn mucus in throat, cough with mucus |
| Chamomilla 3X HPUS | occasional sleeplessness |
| Coffea Cruda 3X HPUS | occasional sleeplessness |
| Euphrasia Offcinalis 6X HPUS | cough with mucus in chest |
| Hepar Sulph Calc 12X HPUS | cough up mucus, mucus rattle with cough, stubborn mucus in chest |
| Hydrastis 6X HPUS | cough with mucus, dry/sore throat, occasional sleeplessness due to mucus in throat |
| Natrum Muriaticum 6X HPUS | accumulation of mucus in throat, cough up mucus |
| Phosphorus 30X HPUS | cough with mucus, chest congestion |
| Pulsatilla 6X HPUS | accumulation of mucus, discharge of mucus, loose cough |
| Rumex Crispus 6X HPUS | runny nose, sneezing |
| Silicea 12X HPUS | nasal congestion |
| Sulphur 12X HPUS | cough with thick mucus, chest congestion, nasal congestion |
"HPUS" is the Homeopathic Pharmacopoeia of the United States.
Uses*
■ Helps temporarily relieve symptoms of common cold in children at night, including:
■ accumulation of mucus in chest, throat or nose
■ cough with mucus ■ runny nose ■ sneezing
■ 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 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 72 hours or worsen.
■ inflammation, fever or infection is present or develops.
■ cough tends to recur or is accompanied by a fever, rash or persistent headache.
Keep out of reach of children
Directions
■ Use as directed. ■ Do not refrigerate. ■ Shake well before using. ■ Measure only with the dosing syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.
| Children under
6 months | Ask a doctor before use. |
| Children 6 months
to under 1 year | 2.5 mL at bedtime and every 6 hours
during the night until relieved. |
| Children 1 year
to under 3 years | 5 mL at bedtime and every 4 hours
during the night until relieved. |
Drug Facts (continued)
Inactive ingredients
Citric Acid, Glycerine,Glycyrrhiza Extract, Purified Water, Sodium Benzoate.
Questions?
www.hylands.com or care@hylands.com
OTC - PURPOSE SECTION
Helps temporarily relieve symptoms of common cold in children at night, including: accumulation of mucus in chest, throat or nose,
cough with mucus, runny nose, sneezing, nasal or chest congestion, occasional sleeplessness.
Indications and Usage
Added asterisk (*) to Uses for Daytime and Nighttime
Principal Display Panel
Hyland's
NATURALS™
•baby•
Mucus + Cold Relief*
COMBO PACK
NO SUGAR, PARABENS or DYES
DAYTIME
Mucus*
Congestion*
Runny Nose*
Sneezing*
Cough*
NIGHTTIME
Sleeplessness*
Mucus*
Congestion*
Runny Nose*
Sneezing*
Cough*
6+ MONTHS
DAYTIME - NO ALCOHOL
NIGHTTIME - LESS THAN 0.2% ALCOHOL
TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)
HOMEOPATHIC
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54973-3284-1 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME | 118 mL in 1 BOTTLE, PLASTIC | LIQUID | 118 mL | 6 [hp_X] in 1mL | 7 |
| 54973-3371-2 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME | 118 mL in 1 BOTTLE | LIQUID | 118 mL | 6 [hp_X] in 1mL | 7 |
| 54973-3374-1 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME | 1 in 1 CARTON | KIT | 1 | 7 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54973-3284 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.] | 7 | Current NDC, Legacy NDC | 20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.zip |
| 54973-3371 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.] | 7 | Current NDC, Legacy NDC | 20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.zip |
| 54973-3374 | BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME (CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA) KIT [HYLAND'S INC.] | 7 | Current NDC, Legacy NDC, 3 package rows | 20230901_7979fc6f-6d2c-56c9-e053-2991aa0ac1f3.zip |
Products#
Every source-derived product name is available through these pages.
- BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME
- calcium sulfide,phosphorus,sulfur,rumex crispus root,sodium chloride,arabica coffee bean,anemone pulsatilla,silicon dioxide, goldenseal,onion,bryonia alba root,euphrasia stricta and matricaria chamomilla
- BABY MUCUS PLUS COLD RELIEF
- bryonia alba root, euphrasia stricta, calcium sulfide, sodium chloride, phosphorus, anemone pulsatilla, rumex crispus root, and silicon dioxide
- SODIUM BENZOATE
- GLYCERIN
- LICORICE
- CITRIC ACID MONOHYDRATE
- WATER
- ANEMONE PULSATILLA
- RUMEX CRISPUS ROOT
- SILICON DIOXIDE
- BRYONIA ALBA ROOT
- EUPHRASIA STRICTA
- CALCIUM SULFIDE
- SODIUM CHLORIDE
- SODIUM CATION
- PHOSPHORUS
- Baby Nighttime Mucus Plus Cold Relief
- GLYCYRRHIZA GLABRA
- ONION
- MATRICARIA CHAMOMILLA
- SULFUR
- ARABICA COFFEE BEAN
- CHLORIDE ION
- GOLDENSEAL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54973-3374 | 54973-3374-1 |
| 54973-3284 | 54973-3284-1 |
| 54973-3371 | 54973-3371-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
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 |
|---|---|---|---|---|---|---|
| BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIME | CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA | Hyland's Inc. | 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3 | 2023-08-23 | Warnings | 54973-3374-1 54973-3284-1 54973-3371-2 54973-3374 54973328401 54973337102 54973337401 0397de56-d497-5ac4-e063-6294a90accb2 7979fc6f-6d2c-56c9-e053-2991aa0ac1f3 |
| BABY MUCUS PLUS COLD RELIEF | BRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDE | Hyland's Inc. | d934cc8a-1e43-4942-858a-05b5d068679a | 2023-08-22 | Warnings | 54973-3284-1 54973-3284 54973328401 |
| Baby Nighttime Mucus Plus Cold Relief | CALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLA | Hyland's Inc. | 736b2487-e81d-d172-e053-2a91aa0ab0cf | 2023-04-17 | Warnings | 54973-3371-2 54973-3371 54973337102 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.