Kids Stuffy Nose and Sinus

Manufacturer: Hyland's Consumer Health Inc.
Effective date: 2022-08-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:18:40

Label at a glance#

ProductKids Stuffy Nose and Sinus

Active ingredientOYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE

Label structure8 sections

Indications and uses

■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: ■ nasal congestion ■ sinus pressure ■ headache

Dosage and administration

■ Use as directed. Children 4 years to under 6 years At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist, 1 tablet every 4 hours until relieved. Children 6 years to under 12 years At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved. Adults and children 12 years and over At onset of...

Contacts and useful links#

Websitewww.hylands.com

www.hylands.com

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

Drug Facts

SPL UNCLASSIFIED SECTION

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Purpose

Calcarea Carbonica 3X HPUS.........................................................................................................sinus pressure, congestion, headache

Hydrastis Canadensis 6X HPUS .....................................................................................................sinus headache

Kali Bichromicum 6X HPUS..............................................................................................................nasal congestion, sinus pressure

Pulsatilla Nigricans 6X HPUS ..........................................................................................................sinus pressure, headache

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

Uses

INDICATIONS & USAGE SECTION

■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:
■ nasal congestion ■ sinus pressure ■ headache

Warnings

WARNINGS SECTION

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever.

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.

Children 4 years to under 6 years	At onset of symptoms, dissolve 1 tablet under tongue every hour up to 4 hours. If symptoms persist, 1 tablet every 4 hours until relieved.
Children 6 years to under 12 years	At onset of symptoms, dissolve 2 tablets under tongue every hour up to 4 hours. If symptoms persist, 2 tablets every 4 hours until relieved.
Adults and children 12 years and over	At onset of symptoms, dissolve 3 tablets under tongue every hour up to 4 hours. If symptoms persist, 3 tablets every 4 hours until relieved.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose

Questions?

OTC - QUESTIONS SECTION

www.hylands.com or care@hylands.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hyland's

NATURALS™

•Kids•

Stuffy Nose

& Sinus*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Nasal Congestion

Sinus Pressure

Headache

4 - 12 YEARS

QUICK-DISSOLVING TABLETS

HOMEOPATHIC

Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54973-4115-1	Kids Stuffy Nose and Sinus	50 in 1 BOTTLE, PLASTIC	TABLET	50		1
54973-4115-1	Kids Stuffy Nose and Sinus	1 in 1 CARTON	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54973-4115	KIDS STUFFY NOSE AND SINUS (OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE) TABLET [HYLAND'S CONSUMER HEALTH INC.]	1	Current NDC, Legacy NDC, 2 package rows	20221201_e7157883-6b23-b61c-e053-2995a90afdc2.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Kids Stuffy Nose and Sinus
OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE
OYSTER SHELL CALCIUM CARBONATE, CRUDE
GOLDENSEAL
POTASSIUM DICHROMATE
DICHROMATE ION
PULSATILLA PRATENSIS WHOLE
ACACIA
LACTOSE MONOHYDRATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54973-4115	54973-4115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OYSTER SHELL CALCIUM CARBONATE, CRUDE	2E32821G6I	ACTIB
GOLDENSEAL	ZW3Z11D0JV	ACTIB
POTASSIUM DICHROMATE	T4423S18FM	ACTIB
PULSATILLA PRATENSIS WHOLE	8E272251DI	ACTIB
ACACIA	5C5403N26O	IACT
LACTOSE MONOHYDRATE	EWQ57Q8I5X	IACT

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 Stuffy Nose and Sinus	OYSTER SHELL CALCIUM CARBONATE, CRUDE, GOLDENSEAL, POTASSIUM DICHROMATE, PULSATILLA PRATENSIS WHOLE	Hyland's Consumer Health Inc.	e7157883-6b23-b61c-e053-2995a90afdc2	2022-08-25	Warnings	Exact identifier ndc (package): 54973-4115-1 ndc (product): 54973-4115 ndc11 (package): 54973411501 spl id: e7157883-6b24-b61c-e053-2995a90afdc2 spl set id: e7157883-6b23-b61c-e053-2995a90afdc2

Reported adverse events (FAERS/openFDA)#

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