Kids Cough and Mucus Daytime Grape Flavor

Manufacturer
Hyland's Consumer Health Inc. | Hyland's INC
Effective date
2024-04-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:26:44

Label at a glance#

ProductKids Cough and Mucus Daytime Grape Flavor
Active ingredientCALCIUM SULFIDE, PHOSPHORUS, ANTIMONY POTASSIUM TARTRATE, RUMEX CRISPUS ROOT, FERROSOFERRIC PHOSPHATE, PULSATILLA VULGARIS WHOLE, BRYONIA ALBA ROOT, IPECAC
Label structure8 sections

Indications and uses

■ Helps temporarily relieve symptoms of common cold in children, including: ■ cough ■ runny nose ■ sneezing ■ sore throat ■ chest or nasal congestion ■ mucus in chest or throat

Dosage and administration

■ Use as directed. ■ Do not refrigerate. ■ 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 4 years to under 6 years 5 mL up to 6 times per day (every 4 hours). Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours). Adults and children 12 years and over 15 mL up to 6 times per day (...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieve symptoms of common cold in children, including: cough, runny nose, sneezing, sore throat, chest or nasal congestion, mucus in chest or throat

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Antimonium Tartaricum 15X HPUS...............................................cough
Bryonia Alba 15X HPUS...............................................................sore throat, mucus in throat, cough
Ferrum Phosphoricum 12X HPUS ...............................................mucus in throat, cough
Hepar Sulph Calc 12X HPUS.......................................................mucus in chest, cough
Ipecacuanha 12X HPUS ..............................................................cough, sore throat
Phosphorus 15X HPUS ...............................................................runny nose, chest or nasal congestion
Pulsatilla 12X HPUS ...................................................................mucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUS ...........................................................runny nose, sneezing

"HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve symptoms of common cold in children, including: ■ cough ■ runny nose ■ sneezing ■ sore throat
■ chest or nasal congestion ■ mucus in chest or throat

Warnings

WARNINGS SECTION

Sore throat warning

SPL UNCLASSIFIED 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 smoking, 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 7 days or worsen. ■ inflammation, fever or infection is present or develops. ■ cough tends to recur or is accompanied by a fever, rash or persistent headache.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 cup provided. ■ Do not use dosing cup with other products.

■ On dosing cup, mL = milliliter.

Children 4 years
to under 6 years
5 mL up to 6 times per day
(every 4 hours).
Children 6 years
to under 12 years
10 mL up to 6 times per day
(every 4 hours).
Adults and children
12 years and over
15 mL up to 6 times per day
(every 4 hours).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•Kids•

Cough &

Mucus

DAYTIME

NO, ALCOHOL, SUGAR,

PARABENS or DYES

Cough

Mucus

Congestion
Runny Nose

EFFECTIVE

MUCUS

RELIEF

4 -12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

CartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor1 in 1 CARTONLIQUID13
54973-4113-1Kids Cough and Mucus Daytime Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID1183

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-4113KIDS COUGH AND MUCUS DAYTIME GRAPE FLAVOR (BRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S CONSUMER HEALTH INC.]3Current NDC, Legacy NDC, 2 package rows20240425_e72c8fdb-2679-86b3-e053-2a95a90a6cdf.zip

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
54973-411354973-4113-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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
Kids Cough and Mucus Daytime Grape FlavorBRYONIA ALBA ROOT,CALCIUM SULFIDE,PULSATILLA VULGARIS WHOLE,FERROSOFERRIC PHOSPHATE,PHOSPHORUS,ANTIMONY POTASSIUM TARTRATE,IPECAC,RUMEX CRISPUS ROOTHyland's Consumer Health Inc.e72c8fdb-2679-86b3-e053-2a95a90a6cdf2024-04-23WarningsExact identifier
ndc (package): 54973-4113-1
ndc (product): 54973-4113
ndc11 (package): 54973411301
spl id: 16c7b1a8-84d8-470b-e063-6394a90a3fbf
spl set id: e72c8fdb-2679-86b3-e053-2a95a90a6cdf

Reported adverse events (FAERS/openFDA)#

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