Baby Mucus Cold Relief Day and Night Value Pack

Manufacturer
Hyland's | Standard Homeopathic Company | Applied Laboratories, Inc. | LGM Pharma Solutions, LLC
Effective date
2021-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:40:55

Label at a glance#

ProductBaby Mucus Cold Relief Day and Night Value Pack
Active ingredientBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, SILICON DIOXIDE, ONION, MATRICARIA RECUTITA, ARABICA COFFEE BEAN, GOLDENSEAL, STRYCHNOS NUX-VOMICA SEED, SULFUR
Label structure14 sections

Indications and uses

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

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

DAYTIME

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.
Bryonia Alba 6X HPUSstubborn mucus in throat, cough with yellowish mucus
Euphrasia Officinalis 6X HPUScough with mucus in chest
Hepar Sulph Calc 12X HPUScough up mucus, mucus rattle with cough, stubborn mucus in chest
Natrum Muriaticum 30X HPUSaccumulation of mucus in throat, cough up mucus
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, sneezing
Silicea 12X HPUSnasal congestion

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms of colds, including accumulation of mucus in chest, throat and nose; cough with expectoration of thick, discolored mucus; runny nose, sneezing and nasal congestion.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

As with any drug ask a doctor before use if pregnant or breast-feeding. 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 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.

SPL UNCLASSIFIED SECTION

NIGHTTIME

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, occasional sleeplessness due to mucus in throat
Natrum Muriaticum 6X HPUSaccumulation of mucus in throat, cough up mucus
Nux Vomica 6X HPUStired, difficulty falling asleep, (0.0000016% Alkaloids, calculated) 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 expectoration of thick, discolored 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 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 - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

New!

NDC 54973-3313-1
HOMEOPATHIC

Ages 6 months+

SINCE 1903
Hyland's ®
Baby

Natural
Relief

Day & Night Value Pack

Daytime

Mucus +
Cold Relief

LOOSENS MUCUS,
RELIEF OF
CONGESTION,
RUNNY NOSE
AND COUGH*

ALCOHOL FREE

4 FL. OZ. (118 mL) Daytime

Nighttime

Mucus +
Cold Relief

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

LESS THAN 0.2% ALCOHOL

4 FL. OZ. (118 mL) Nighttime

▶ No Artificial Flavors, Dyes or Parabens

8 FL. OZ. (236 mL) TOTAL

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-331354973-3313-1
54973-328454973-3284-1
54973-325154973-3251-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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 · 3 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): 54973-3284-1
ndc11 (package): 54973328401
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
ndc (package): 54973-3284-1
ndc (product): 54973-3284
ndc11 (package): 54973328401
eea18052-6aa1-d9cb-e053-2a95a90a047b45eb3326-1310-4044-997c-42c4abc6789d2022-11-29WarningsExact identifier
spl set id: 45eb3326-1310-4044-997c-42c4abc6789d

Reported adverse events (FAERS/openFDA)#

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