Kids Stuffy Nose & Sinus

SPL v6

SPL

SPL Set ID a00f1db3-cae4-5729-e053-2a95a90ab001

Route

ORAL

Published

Effective Date 2023-03-01

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Oyster Shell Calcium Carbonate, Crude (3 [hp_X]) Goldenseal (6 [hp_X]) Dichromate Ion Pulsatilla Pratensis Whole

Inactive Ingredients

Acacia Anhydrous Lactose

Identifiers & Packaging

Pill Appearance

Shape: round Color: white Size: 9 mm Score: 1

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2020-01-27 Until 2023-03-06

Description

Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

Indications and Usage

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

Medication Information

Indications and Usage

Uses

Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:

nasal congestion sinus pressure headache

Description

Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

Uses

■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:

■ nasal congestion

■ sinus pressure

■ headache

Section 55105-1

Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

Directions

■ Use as directed.

Children 2 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.

Questions?

www.hylands.com or [email protected]

Active Ingredients

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.

Inactive Ingredients

Acacia Gum, Lactose.

Principal Display Panel

Hyland's

•kids•

STUFFY NOSE

& SINUS*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Nasal Congestion

Sinus Pressure

Headache

2- 12 YEARS

^{QUICK-DISSOLVING TABLETS}

HOMEOPATHIC

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If

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

Structured Label Content

Uses

■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:

■ nasal congestion

■ sinus pressure

■ headache

Section 55105-1 (55105-1)

Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache

Directions

■ Use as directed.

Children 2 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.

Questions?

www.hylands.com or [email protected]

Active Ingredients (Active ingredients)

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.

Inactive Ingredients (Inactive ingredients)

Acacia Gum, Lactose.

Indications and Usage

Uses

Helps temporarily relieve symptoms of stuffy nose and sinus in children, including:

nasal congestion sinus pressure headache

Principal Display Panel

Hyland's

•kids•

STUFFY NOSE

& SINUS*

NO ARTIFICIAL FLAVORS,

DYES or PARABENS

Nasal Congestion

Sinus Pressure

Headache

2- 12 YEARS

^{QUICK-DISSOLVING TABLETS}

HOMEOPATHIC

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Advanced Ingredient Data

[{"name": "OYSTER SHELL CALCIUM CARBONATE, CRUDE", "unii": "2E32821G6I", "classCode": "ACTIB", "strengthNumerator": "3", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "GOLDENSEAL", "unii": "ZW3Z11D0JV", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "DICHROMATE ION", "unii": "9LKY4BFN2V", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}, {"name": "ACACIA", "unii": "5C5403N26O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS LACTOSE", "unii": "3SY5LH9PMK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PULSATILLA PRATENSIS WHOLE", "unii": "8E272251DI", "classCode": "ACTIB", "strengthNumerator": "6", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_X]", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "■ Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: ■ nasal congestion ■ sinus pressure ■ headache", "55105-1": "Temporarily relieves symptoms of stuffy nose and sinus in children, including: nasal congestion, sinus pressure, headache", "Directions": "■ Use as directed. Children 2 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.", "Questions?": "www.hylands.com or care@hylands.com", "Active ingredients": "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.", "Inactive ingredients": "Acacia Gum, Lactose.", "Indications and Usage": "Uses Helps temporarily relieve symptoms of stuffy nose and sinus in children, including: nasal congestion sinus pressure headache", "Principal Display Panel": "Hyland's •kids• STUFFY NOSE & SINUS* NO ARTIFICIAL FLAVORS, DYES or PARABENS Nasal Congestion Sinus Pressure Headache 2- 12 YEARS 50 QUICK-DISSOLVING TABLETS HOMEOPATHIC", "If pregnant or breastfeeding": "ask a health professional before use.", "Stop use and ask a doctor if": "■ symptoms persist for more than 72 hours or worsen. ■ symptoms are accompanied by a fever."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:12:04.224311 · Updated: 2026-03-14T23:17:25.374093