FDA.reportPublic FDA data

Cold and Mucus

Manufacturer
Wal-Mart Stores, Inc.
Effective date
2022-12-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 21:44:16

Label at a glance#

ProductCold and Mucus
Active ingredientEUPHRASIA STRICTA, RUMEX CRISPUS ROOT, SODIUM CHLORIDE, PHOSPHORUS, SILICON DIOXIDE, BRYONIA ALBA ROOT, CALCIUM SULFIDE, ANEMONE PULSATILLA
Label structure8 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

Directions Shake well before using. Measure only with the dosing cup provided. Do not use dosing cup with other products. On dosing cup, mL = milliliter.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients

Purpose

Bryonia Alba 6X HPUS

stubborn mucus in throat, cough with yellowish 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 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

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

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.

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 medical professional.

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well before using.
  • Measure only with the dosing cup provided.
  • Do not use dosing cup with other products.
  • On dosing cup, mL = milliliter.

Children 2 years

to under 6 years

5mL up to 6 times per day

(every 4 hours)

Children 6 years

to under 12 years

10mL up to 6 times per day

(every 4 hours)

Adults and children

12 years and under

15mL up to 6 times per day

(every 4 hours)

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Dosage and Administration

RECENT MAJOR CHANGES SECTION

Directions

Shake well before using.

Measure only with the dosing cup provided.

Do not use dosing cup with other products.

On dosing cup, mL = milliliter.

Principal Display Panel - 4 FL OZ (118 mL) Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-926-01

Equate™

Compare to

Hyland’s 4 Kids

Cold ’n Mucus

Alcohol Free, Sugar Free, Dye Free

Homeopathic

Children's

Cold & Mucus*

Daytime

AGES 2 to 12 YEARS

For Temporary Relief of:

  • Mucus & Congestion
  • Runny Nose
  • Cough

*Claims based on traditional

homeopathic practice, not

accepted medical evidence.

Not FDA evaluated.

4 FL OZ (118 mL)

cartoncarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-926-012022-03-11C16284748780-1c7ccaba7-1623-fd44-e053-dadaa90aa01bEquate Children's Cold & Mucus Daytime
49035-926-012021-07-23C16284748780-1c7ccaba7-1623-fd44-e053-dadaa90aa01bEquate Children's Cold & Mucus Daytime

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-92649035-926-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
EUPHRASIA STRICTAC9642I91WLACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORUS27YLU75U4WACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB

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
087aa01e-3894-f435-e063-6394a90a8766696e0888-b4ba-3b29-e053-2a91aa0a3f752023-10-24WarningsExact identifier
spl set id: 696e0888-b4ba-3b29-e053-2a91aa0a3f75

Reported adverse events (FAERS/openFDA)#

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