Childrens Nighttime Cold and Mucus

Manufacturer
Wal-Mart Stores, Inc
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:44:16

Label at a glance#

ProductChildrens Nighttime Cold and Mucus
Active ingredientONION, BRYONIA ALBA ROOT, ARABICA COFFEE BEAN, RUMEX CRISPUS ROOT, GOLDENSEAL, ANEMONE PULSATILLA, SILICON DIOXIDE, SULFUR, MATRICARIA CHAMOMILLA, EUPHRASIA STRICTA, SODIUM CHLORIDE, CALCIUM SULFIDE, PHOSPHORUS
Label structure6 sections

Dosage and administration

 Measure only with the dosing cup provided  Do not use dosing cup with other products  On dosing cup, mL = milliliter, tsp = teaspoon Children 2 years to under 6 years 5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary Children 6 years to under 12 years 10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary Adults and children 12 years and over 15 mL or ...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE 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 yellowish mucus

Chamomilla 3X HPUS

irritability, fussiness, occasional sleeplessness

Coffea Cruda 3X HPUS

occasional sleeplessness, restlessness

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 expectoration of yellow mucus, chest congestion

Pulsatilla 6X HPUS

accumulation of mucus, discharge of thick yellowish 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” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of the common cold in children especially at night including accumulation of mucus in chest, throat and nose, cough with mucus, runny nose, sneezing, nasal congestion and occasional sleeplessness.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional

Persistent cough

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious condition.

Sore throat warning

SPL UNCLASSIFIED SECTION

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 imprinted tamper band is broken or missing.

In case of emergency

SPL UNCLASSIFIED SECTION

In case of emergency, contact a medical professional or Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  •  Measure only with the dosing cup provided
  •  Do not use dosing cup with other products
  •  On dosing cup, mL = milliliter, tsp = teaspoon

Children 2 years to under 6 years

5 mL or 1 teaspoon at bedtime and every 4 hours during the night or as necessary

Children 6 years to under 12 years

10 mL or 2 teaspoons at bedtime and every 4 hours during the night or as necessary

Adults and children 12 years and over

15 mL or 3 teaspoons at bedtime and every 4 hours during the night or as necessary

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 118 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-922-01

Compare to

Hyland’s 4 Kids

Cold ’n Mucus

Nighttime

Equate™

Less than 0.2% Alcohol, Sugar free, Dye Free

Homeopathic

Children's

Cold & Mucus*

Nighttime

AGES 2 to 12 YEARS

For Temporary Relief of:

  • Mucus & Congestion
  • Occasional Sleeplessness
  • Runny nose
  • Cough

4 FL OZ (118 mL)

*Claims based on traditional homeopathic practice, not

accepted medical evidence. Not FDA evaluated.

label2label2

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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-922-012021-12-21C16284748780-1c7ccaba7-1959-fd44-e053-dadaa90aa01bEquate Children's Nighttime Cold & Mucus
49035-922-012021-07-23C16284748780-1c7ccaba7-1959-fd44-e053-dadaa90aa01bEquate Children's Nighttime Cold & Mucus

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
49035-92249035-922-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
087a849c-a640-2def-e063-6294a90aa29e6a262fb4-d355-59a8-e053-2991aa0a35e62023-10-24WarningsExact identifier
spl set id: 6a262fb4-d355-59a8-e053-2991aa0a35e6

Reported adverse events (FAERS/openFDA)#

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