Cough and Mucus Grape Flavor

Manufacturer
Hyland's | Hylands | LGM Pharma Solutions, LLC
Effective date
2025-10-29
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:37:28

Label at a glance#

ProductCough and Mucus Grape Flavor
Active ingredientRUMEX CRISPUS ROOT, BRYONIA ALBA ROOT, ANEMONE PULSATILLA, PHOSPHORUS, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, IPECAC, ANTIMONY POTASSIUM TARTRATE
Label structure8 sections

Indications and uses

■ Temporarily relieves 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 = millilite Children 2 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 (ev...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves 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 HPUScough
Bryonia Alba 15X HPUSsore throat, mucus in throat, cough
Ferrum Phosphoricum 12X HPUSmucus in throat, cough
Hepar Sulph Calc 12X HPUSmucus in chest, cough
Ipecacuanha 12X HPUScough, sore throat
Phosphorus 15X HPUSrunny nose, chest or nasal congestion
Pulsatilla 12X HPUSmucus in chest or throat, cough, sneezing
Rumex Crispus 6X HPUSrunny nose, sneezing

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

Uses

INDICATIONS & USAGE SECTION

■ Temporarily relieves 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 = millilite

Children 2 years to under 6 years5 mL up to 6 times per day (every 4 hours).
Children 6 years to under 12 years10 mL up to 6 times per day (every 4 hours).
Adults and children 12 years and over15 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.

PACKAGE LABEL - 118 mL BOTTLE CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•kids•

NEW

Cough &

Mucus

DAYTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES*

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ (118 mL)

HOMEOPATHIC

CartonCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4056-1Cough and Mucus Grape Flavor1 in 1 CARTONLIQUID110
54973-4056-1Cough and Mucus Grape Flavor118 mL in 1 BOTTLE, PLASTICLIQUID11810
54973-4056-3Cough and Mucus Grape Flavor5 mL in 1 POUCHLIQUID510

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
54973-405654973-4056-1, 54973-4056-3

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92024-05-02full-release2026-06-01 02:26:51

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cough and Mucus Grape FlavorANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,FERROSOFERRIC PHOSPHATE,CALCIUM SULFIDE,IPECAC,PHOSPHORUS,ANEMONE PULSATILLA,RUMEX CRISPUS ROOTHyland'sd0eb15c6-bf12-19b7-e053-2a95a90abbe02025-10-29WarningsExact identifier
ndc (package): 54973-4056-1
ndc (package): 54973-4056-3
ndc (product): 54973-4056
ndc11 (package): 54973405603
ndc11 (package): 54973405601
spl id: 4254eeba-6fb5-d20f-e063-6394a90a5278
spl set id: d0eb15c6-bf12-19b7-e053-2a95a90abbe0
Kids Cough and Mucus Day and Night GrapeRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Inc.d92ab90b-b960-3df2-e053-2a95a90ace892025-06-25WarningsExact identifier
ndc (package): 54973-4056-1
ndc11 (package): 54973405601

Reported adverse events (FAERS/openFDA)#

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