Kids Cough and Mucus Nighttime Grape

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 Nighttime Grape

Active ingredientRUMEX CRISPUS ROOT, FERROSOFERRIC PHOSPHATE, GOLDENSEAL, IPECAC, ANTIMONY POTASSIUM TARTRATE, PHOSPHORUS, BRYONIA ALBA ROOT, CHAMOMILE, PULSATILLA VULGARIS, CALCIUM SULFIDE

Label structure8 sections

Indications and uses

■ 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

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 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...

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

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

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients	Purpose
Antimonium Tartaricum 15X HPUS..............................................	cough
Bryonia Alba 15X HPUS..............................................................	sore throat, mucus in throat, cough
Chamomilla 6X HPUS.................................................................	occasional sleeplessness
Ferrum Phosphoricum 12X HPUS ...............................................	mucus in throat, cough
Hepar Sulph Calc 12X HPUS.......................................................	mucus in chest, coug
Hydrastis Canadensis 15X HPUS................................................	occasional sleeplessness due to mucus in throat
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 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

Children 4 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.

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•Kids•

Cough &

Mucus*

NIGHTTIME

NO ALCOHOL, SUGAR,

PARABENS or DYES

Sleeplessness

Cough

Mucus

Congestion

Runny Nose

EFFECTIVE

MUCUS

RELIEF

4 - 12

YEARS

NATURAL

GRAPE FLAVOR

4 FL. OZ. (118 mL)

HOMEOPATHIC

Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54973-4114-1	Kids Cough and Mucus Nighttime Grape	118 mL in 1 BOTTLE, PLASTIC	LIQUID	118		3
54973-4114-1	Kids Cough and Mucus Nighttime Grape	1 in 1 BOTTLE, PLASTIC	LIQUID	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-4114	KIDS COUGH AND MUCUS NIGHTTIME GRAPE (ANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,CALCIUM SULFIDE,CHAMOMILE,FERROSOFERRIC PHOSPHATE,GOLDENSEAL,IPECAC,PHOSPHORUS,PULSATILLA VULGARIS,RUMEX CRISPUS ROOT) LIQUID [HYLAND'S CONSUMER HEALTH INC.]	3	Current NDC, Legacy NDC, 2 package rows	20240425_e76509f9-6219-908e-e053-2a95a90a21b3.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

Kids Cough and Mucus Nighttime Grape
ANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,CALCIUM SULFIDE,CHAMOMILE,FERROSOFERRIC PHOSPHATE,GOLDENSEAL,IPECAC,PHOSPHORUS,PULSATILLA VULGARIS,RUMEX CRISPUS ROOT
CITRIC ACID MONOHYDRATE
GLYCERIN
GLYCYRRHIZA GLABRA
WATER
SODIUM BENZOATE
RUMEX CRISPUS ROOT
FERROSOFERRIC PHOSPHATE
GOLDENSEAL
IPECAC
ANTIMONY POTASSIUM TARTRATE
ANTIMONY CATION (3+)
PHOSPHORUS
BRYONIA ALBA ROOT
CHAMOMILE
PULSATILLA VULGARIS
CALCIUM SULFIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-4114	54973-4114-1

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
Name	UNII	Kind
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCYRRHIZA GLABRA	2788Z9758H	IACT
WATER	059QF0KO0R	IACT
SODIUM BENZOATE	OJ245FE5EU	IACT
RUMEX CRISPUS ROOT	9N1RM2S62C	ACTIB
FERROSOFERRIC PHOSPHATE	91GQH8I5F7	ACTIB
GOLDENSEAL	ZW3Z11D0JV	ACTIB
IPECAC	62I3C8233L	ACTIB
ANTIMONY POTASSIUM TARTRATE	DL6OZ476V3	ACTIB
PHOSPHORUS	27YLU75U4W	ACTIB
BRYONIA ALBA ROOT	T7J046YI2B	ACTIB
CHAMOMILE	FGL3685T2X	ACTIB
PULSATILLA VULGARIS	I76KB35JEV	ACTIB
CALCIUM SULFIDE	1MBW07J51Q	ACTIB

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kids Cough and Mucus Nighttime Grape	ANTIMONY POTASSIUM TARTRATE,BRYONIA ALBA ROOT,CALCIUM SULFIDE,CHAMOMILE,FERROSOFERRIC PHOSPHATE,GOLDENSEAL,IPECAC,PHOSPHORUS,PULSATILLA VULGARIS,RUMEX CRISPUS ROOT	Hyland's Consumer Health Inc.	e76509f9-6219-908e-e053-2a95a90a21b3	2024-04-23	Warnings	Exact identifier ndc (package): 54973-4114-1 ndc (product): 54973-4114 ndc11 (package): 54973411401 spl id: 16c7c964-18cd-2bc5-e063-6394a90aa45b spl set id: e76509f9-6219-908e-e053-2a95a90a21b3

Reported adverse events (FAERS/openFDA)#

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