Baby Nighttime Mucus Cold Relief

Manufacturer
Hyland's | Standard Homeopathic Company | LGM Pharma Solutions, LLC | Applied Laboratories, Inc.
Effective date
2021-07-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:41:20

Label at a glance#

ProductBaby Nighttime Mucus Cold Relief
Active ingredientONION, BRYONIA ALBA ROOT, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, EUPHRASIA STRICTA, CALCIUM SULFIDE, GOLDENSEAL, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE, SULFUR
Label structure8 sections

Indications and uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and irritability, fussiness and occasional sleeplessness.

Dosage and administration

Measure only with the dosing syringe provided Do not use dosing syringe with other products On dosing syringe, mL = milliliter, tsp = teaspoon Children under 6 months of age consult a licensed health care professional before using this product Children 6 months to under 1 year of age 2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours) Children 1 to 3 years of age 5 mL or 1 teaspoon up to 6 times daily (every ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Allium Cepa 6X HPUSrunny nose with mucus, hacking cough, sore throat
Bryonia Alba 6X HPUSstubborn mucus in throat, cough with yellowish mucus
Chamomilla 3X HPUSirritability, fussiness, occasional sleeplessness
Coffea Cruda 3X HPUSoccasional sleeplessness, restlessness
Euphrasia Officinalis 6X HPUScough with mucus in chest
Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
Hydrastis 6X HPUScough with mucus, dry, sore throat, sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUSaccumulation of mucus in throat, cough up mucus
Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)tired, difficulty falling asleep, frequent waking
Phosphorus 30X HPUScough with expectoration of yellow mucus, chest congestion
Pulsatilla 6X HPUSaccumulation of mucus, discharge of thick yellowish mucus, loose cough
Rumex Crispus 6X HPUSrunny nose and sneezing
Silicea 12X HPUSnasal congestion
Sulphur 12X HPUScough with thick mucus, chest congestion, nasal congestion

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and irritability, fussiness and occasional sleeplessness.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

Consult a physician if:

  • Symptoms persist for more than 7 days or worsen
  • Inflammation, fever or infection develops
  • Symptoms are accompanied by high fever (101°F)
  • Cough tends to recur or is accompanied by high fever, rash or persistent headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose contact a medical professional or a Poison Control Center immediately.

OTC - DO NOT USE SECTION

Do not use this product for persistent or chronic cough such as asthma, smoking, emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious condition. Sore throat warning: Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use if preprinted tamper band is broken or missing.

SPL UNCLASSIFIED SECTION

In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland's may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Measure only with the dosing syringe provided
  • Do not use dosing syringe with other products
  • On dosing syringe, mL = milliliter, tsp = teaspoon
Children under 6 months of ageconsult a licensed health care professional before using this product
Children 6 months to under 1 year of age2.5 mL or ½ teaspoon up to 4 times daily (every 6 hours)
Children 1 to 3 years of age5 mL or 1 teaspoon up to 6 times daily (every 4 hours)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ages 6 months+

NDC 54973-3251-1

HOMEOPATHIC

SINCE 1903

Hyland's
Baby

Natural
Relief

Nighttime
Mucus +
Cold Relief

LOOSENS MUCUS,
RELIEF OF CONGESTION,
AND OCCASIONAL
SLEEPLESSNESS DUE
TO COLDS*

►No Artificial Flavors,
Dyes or Parabens

LESS THAN 0.2% ALCOHOL

4 FL.OZ. (118 mL)

0101

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-325154973-3251-1, 54973-3251-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
eea04c44-6202-89a8-e053-2a95a90ae5620f60901c-5316-4805-8a82-4bf06350a8942022-11-29WarningsExact identifier
spl set id: 0f60901c-5316-4805-8a82-4bf06350a894

Reported adverse events (FAERS/openFDA)#

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