FDA.reportPublic FDA data

Baby Nighttime Mucus Plus Cold Relief

Manufacturer
Hyland's Inc.
Effective date
2023-04-17
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:20:54

Label at a glance#

ProductBaby Nighttime Mucus Plus Cold Relief
Active ingredientCALCIUM SULFIDE, PHOSPHORUS, ANEMONE PULSATILLA, SILICON DIOXIDE, GOLDENSEAL, ONION, BRYONIA ALBA ROOT, EUPHRASIA STRICTA, MATRICARIA CHAMOMILLA, ARABICA COFFEE BEAN, SODIUM CHLORIDE, RUMEX CRISPUS ROOT, SULFUR
Label structure11 sections

Indications and uses

■ Temporarily relieves 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

Dosage and administration

■ 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 ...

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Relieves mucus, congestion, runny nose, sneezing, cough and occasional sleeplessness

Drug Facts

SPL UNCLASSIFIED SECTION

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 Officinalis 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

Sulfur 12X HPUS

cough with thick mucus, chest congestion, nasal congestion

SPL UNCLASSIFIED SECTION

"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves 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

WARNINGS SECTION

Sore throat warning:

OTC - ASK DOCTOR 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 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 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.

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 syringe provided. ■ Do not use dosing syringe with other products. ■ On dosing syringe, mL = milliliter.

Children under 6 monthsAsk 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Indications and Usage

RECENT MAJOR CHANGES SECTION

Added bullet

Dosage and Administration (Directions)

RECENT MAJOR CHANGES SECTION

■ 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

Consult a physician.

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 3 years

5 mL at bedtime and every

4 hours during the night

until relieved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton2carton2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
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ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54973-3371-12021-11-17C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime
54973-3371-22021-11-17C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime
54973-3371-32021-11-17C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime
54973-3371-12021-07-23C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime
54973-3371-22021-07-23C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime
54973-3371-32021-07-23C16284748780-1c7ccaba7-206a-fd44-e053-dadaa90aa01bHyland's Naturals Baby Mucus + Cold Relief Nighttime

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3371-1Baby Nighttime Mucus Plus Cold Relief1 in 1 CARTONLIQUID17
54973-3371-1Baby Nighttime Mucus Plus Cold Relief148 mL in 1 BOTTLE, PLASTICLIQUID1487
54973-3371-2Baby Nighttime Mucus Plus Cold Relief118 mL in 1 BOTTLE, PLASTICLIQUID1187
54973-3371-2Baby Nighttime Mucus Plus Cold Relief1 in 1 CARTONLIQUID17
54973-3371-3Baby Nighttime Mucus Plus Cold Relief2.5 mL in 1 PACKETLIQUID2.57

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3371BABY 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) LIQUID [HYLAND'S INC.]7Current NDC, Legacy NDC, 5 package rows20230419_736b2487-e81d-d172-e053-2a91aa0ab0cf.zip

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
54973-337154973-3371-1, 54973-3371-2, 54973-3371-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
CALCIUM SULFIDE1MBW07J51QACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
GOLDENSEALZW3Z11D0JVACTIB
ONION492225Q21HACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
MATRICARIA CHAMOMILLAG0R4UBI2ZZACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABY MUCUS PLUS COLD RELIEF DAYTIME AND NIGHTTIMECALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.7979fc6f-6d2c-56c9-e053-2991aa0ac1f32023-08-23WarningsExact identifier
ndc (package): 54973-3371-2
ndc11 (package): 54973337102
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
ndc (package): 54973-3371-3
ndc (package): 54973-3371-1
ndc (package): 54973-3371-2
ndc (product): 54973-3371
ndc11 (package): 54973337101
ndc11 (package): 54973337102
ndc11 (package): 54973337103
spl id: f98bd339-1709-6f48-e053-6394a90ad617
spl set id: 736b2487-e81d-d172-e053-2a91aa0ab0cf

Reported adverse events (FAERS/openFDA)#

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