FDA.reportPublic FDA data

Kids Cough and Mucus Day and Night Grape

Manufacturer
Hyland's Inc.
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:34:07

Label at a glance#

ProductKids Cough and Mucus Day and Night Grape
Active ingredientMATRICARIA CHAMOMILLA WHOLE, CALCIUM SULFIDE, RUMEX CRISPUS ROOT, PHOSPHORUS, GOLDENSEAL, IPECAC, PULSATILLA VULGARIS, BRYONIA ALBA ROOT, FERROSOFERRIC PHOSPHATE, ANTIMONY POTASSIUM TARTRATE, ANEMONE PULSATILLA
Label structure19 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 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 (...

Label contents#

Full prescribing information#

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

■ 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

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.

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 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
(every 4 hours).

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Antimonium Tartaricum 15X HPUScough
Bryonia Alba 15X HPUSsore throat, mucus in throat, cough
Chamomilla 6X HPUSoccasional sleeplessness
Ferrum Phosphoricum 12X HPUSmucus in throat, cough
Hepar Sulph Calc 12X HPUSmucus in chest, cough
Hydrastis Canadensis 15X HPUSoccasional sleeplessness due to mucus in throat
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

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

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.

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 2 years
to under 6 years 		5 mL at bedtime and every 4 hours
during the night until relieved.
Children 6 years
to under 12 years 		10 mL at bedtime and every 4 hours
during the night until relieved.
Adults and children
12 years and over 		15 mL at bedtime and every 4 hours
during the night until relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Helps temporarily relieve symptoms of common cold in children at night, including: cough, runny nose, sneezing, sore throat,
chest or nasal congestion, mucus in chest or throat, occasional sleeplessness.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•Kids•

Cough & Mucus*

COMBO PACK

NO ALCOHOL, SUGAR, PARABENS or DYES

DAYTIME

Cough

Mucus

Runny Nose

NIGHTTIME

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

2 - 12 YEARS

EFFECTIVE

MUCUS

RELIEF

NATURAL

GRAPE FLAVOR

TWO - 4 FL. OZ. (118 mL) Bottles (1 Day, 1 Night)

HOMEOPATHIC

CMCDNFL240CTNF1H1CMCDNFL240CTNF1H1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-4056-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID12 [hp_X] in 1mL10
54973-4056-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4056-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Day and Night Grape118 mL in 1 BOTTLE, PLASTICLIQUID118 mL12 [hp_X] in 1mL10
54973-4057-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONLIQUID15 [hp_X] in 1mL10
54973-4057-2Kids Cough and Mucus Day and Night Grape5 mL in 1 POUCHLIQUID6 [hp_X] in 1mL10
54973-4059-1Kids Cough and Mucus Day and Night Grape1 in 1 CARTONKIT110

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-405954973-4059-1
54973-405754973-4057-1, 54973-4057-2
54973-405654973-4056-1, 54973-4056-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
PHOSPHORUS27YLU75U4WACTIB
GOLDENSEALZW3Z11D0JVACTIB
IPECAC62I3C8233LACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
ANEMONE PULSATILLAI76KB35JEVACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
IPECAC62I3C8233LACTIB
PHOSPHORUS27YLU75U4WACTIB
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM SULFIDE1MBW07J51QACTIB

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
Kids Cough and Mucus Nighttime Grape FlavorRUMEX CRISPUS ROOT, ANTIMONY POTASSIUM TARTRATE, BRYONIA ALBA ROOT, MATRICARIA CHAMOMILLA WHOLE, PULSATILLA VULGARIS, CALCIUM SULFIDE, IPECAC, GOLDENSEAL, PHOSPHORUS, FERROSOFERRIC PHOSPHATEHyland's Consumer Health Inc.d83e7877-f599-b364-e053-2995a90ab35f2026-02-19WarningsExact identifier
ndc (package): 54973-4057-1
ndc (product): 54973-4057
ndc11 (package): 54973405701
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 (product): 54973-4056
ndc11 (package): 54973405601
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): 54973-4057-1
ndc (package): 54973-4056-1
ndc (package): 54973-4056-2
ndc (package): 54973-4059-1
ndc (package): 54973-4057-2
ndc (product): 54973-4059
ndc11 (package): 54973405601
ndc11 (package): 54973405702
ndc11 (package): 54973405602
ndc11 (package): 54973405701
ndc11 (package): 54973405901
spl id: 38720b49-2950-dba1-e063-6294a90acede
spl set id: d92ab90b-b960-3df2-e053-2a95a90ace89

Reported adverse events (FAERS/openFDA)#

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