FDA.reportPublic FDA data

Kids Cough and Mucus Nighttime Cherry Berry

Manufacturer
Hyland's | Standard Homeopathic Company | LGM Pharma Solutions, LLC
Effective date
2022-02-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:07:42

Label at a glance#

ProductKids Cough and Mucus Nighttime Cherry Berry
Active ingredientANTIMONY POTASSIUM TARTRATE, FERROSOFERRIC PHOSPHATE, CALCIUM SULFIDE, BRYONIA ALBA ROOT, IPECAC, MATRICARIA RECUTITA, GOLDENSEAL, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT
Label structure8 sections

Indications and uses

Temporarily relieves 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

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 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 1...

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Temporarily relieves 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

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

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

Temporarily relieves 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

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 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 Cherry Flavor, Natural Strawberry Flavor, Purified Water, Sodium Benzoate.

Package Label - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

Naturals™

•Kids•

New

Cough &

Mucus

NIGHTTIME*

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

2-12

YEARS

NATURAL CHERRY

BERRY FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

CartonCarton

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-406354973-4063-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ANTIMONY POTASSIUM TARTRATEDL6OZ476V3ACTIB
GLYCYRRHIZA GLABRA2788Z9758HIACT
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB
CALCIUM SULFIDE1MBW07J51QACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
IPECAC62I3C8233LACTIB
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
GOLDENSEALZW3Z11D0JVACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
RUMEX CRISPUS ROOT9N1RM2S62CACTIB
CITRIC ACID MONOHYDRATE2968PHW8QPIACT

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
e1faad89-8db7-86a3-e053-2a95a90a7d32d8ca1d1f-f947-480b-e053-2a95a90a096e2022-06-21WarningsExact identifier
spl set id: d8ca1d1f-f947-480b-e053-2a95a90a096e

Reported adverse events (FAERS/openFDA)#

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