FDA.reportPublic FDA data

SNIFFLES N SNEEZES 4 KIDS

Manufacturer
Hyland's Inc.
Effective date
2022-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:18:52

Label at a glance#

ProductSNIFFLES N SNEEZES 4 KIDS
Active ingredientACONITUM NAPELLUS ROOT, ONION, GELSEMIUM SEMPERVIRENS ROOT, ZINC GLUCONATE
Label structure7 sections

Indications and uses

Temporarily relieves the symptoms of the common cold, including: sneezing cough watery eyes runny nose sore throat headache

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Active ingredientsPurpose
Acontitum Napellus 6X HPUS

sneezing, watery eyes, sore throat

Allium Cepa 6X HPUS

red/watery eyes, runny nose, nasal discharge

Gelsemium Sempervirens 6X HPUS

sneezing, headache, sore throat, cough

Zincum Gluconium 2X HPUS

runny nose and sore throat

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

INDICATIONS & USAGE SECTION

Uses

OTC - PURPOSE SECTION

Temporarily relieves the symptoms of the common cold, including:

  • sneezing
  • cough
  • watery eyes
  • runny nose
  • sore throat
  • headache

Warnings

WARNINGS SECTION

As with any drug, ask a doctor before use if pregnant or breast-feeding.

SPL UNCLASSIFIED SECTION

Consult a physician if:

  • symptoms persist for more than 7 days or worsen.
  • inflammation, fever or infection develops.
  • symptoms are accompanied by a high fever (over 101°F).
  • cough tends to recur or is accompanied by a high fever, rash or persistent headache.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children.

In case of accidental overdose, contact a medical professional or a poison control center immediately.

OTC - DO NOT USE SECTION

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

OTC - WHEN USING SECTION

A persistent cough may be a sign of a serious condition.

SPL UNCLASSIFIED SECTION

Sore throat warning severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

OTC - DO NOT USE SECTION

Do not use if imprinted tamper-evident bottle cap band is broken or missing.

SPL UNCLASSIFIED SECTION

The inner packaged bottle is child-resistant. In case of emergency, contact a medical professional or Poison Control Center immediately. Hyland’s may also be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

Children 2 years to under 6 yearsdissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
Children 6 years to under 12 yearsdissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
Adults and children 12 years and overdissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natural
Relief

NDC 54973-3160-1
HOMEOPATHIC

Ages
2-12

SINCE 1903

Hyland's ®
4Kids

Sniffles 'n
Sneezes

Runny Nose & Sore Throat

Sneezing

Cough

ACTUAL SIZE 65 MG

125 QUICK-DISSOLVING TABLETS

*SEE NOTE ON BACK PANEL BELOW DRUG FACTS

cartoncarton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54973-3160-1SNIFFLES N SNEEZES 4 KIDS125 in 1 BOTTLE, PLASTICTABLET1254
54973-3160-1SNIFFLES N SNEEZES 4 KIDS1 in 1 CARTONTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-3160SNIFFLES N SNEEZES 4 KIDS (ACONITUM NAPELLUS ROOT, ONION, GELSEMIUM SEMPERVIRENS ROOT, AND ZINC GLUCONATE) TABLET [HYLAND'S INC.]4Current NDC, Legacy NDC, 2 package rows20221217_323340a5-b493-42cd-87c6-9398cd06554e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUS ROOTACTIVE INGREDIENTKPD2N7348X1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
ONIONACTIVE INGREDIENT492225Q21H1
ZINC GLUCONATEACTIVE INGREDIENTU6WSN5SQ1Z1
ACONITUM NAPELLUS ROOTACTIVE MOIETYKPD2N7348X1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
ONIONACTIVE MOIETY492225Q21H1
ZINC CATIONACTIVE MOIETY13S1S8SF371
ACACIAINACTIVE INGREDIENT5C5403N26O1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-316054973-3160-1

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
NameUNIIKind
ACACIA5C5403N26OIACT
LACTOSEJ2B2A4N98GIACT
ACONITUM NAPELLUS ROOTKPD2N7348XACTIB
ONION492225Q21HACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
ZINC GLUCONATEU6WSN5SQ1ZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
SNIFFLES N SNEEZES 4 KIDSACONITUM NAPELLUS ROOT, ONION, GELSEMIUM SEMPERVIRENS ROOT, AND ZINC GLUCONATEHyland's Inc.323340a5-b493-42cd-87c6-9398cd06554e2022-12-14WarningsExact identifier
ndc (package): 54973-3160-1
ndc (product): 54973-3160
ndc11 (package): 54973316001
spl id: efce3b89-2e8f-20c8-e053-2a95a90af89b
spl set id: 323340a5-b493-42cd-87c6-9398cd06554e

Reported adverse events (FAERS/openFDA)#

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