FDA.reportPublic FDA data

4 Kids Sore Throat Grape

Manufacturer
Hyland's Inc. | Applied Laboratories, Inc.
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:18:37

Label at a glance#

Product4 Kids Sore Throat Grape
Active ingredientCALCIUM SULFIDE, PHOSPHORUS, ACONITUM NAPELLUS, SPONGIA OFFICINALIS SKELETON, ROASTED, FERROSOFERRIC PHOSPHATE
Label structure9 sections

Indications and uses

Temporarily relieves sore throat symptoms in children, including: occasional minor irritation  pain

Dosage and administration

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 up to 6 times per day (every 4 hours). Children 6 years to under 12 years 10 mL up to 6 times per day (every 4 hours). Adults and children 12 years and over 15 mL up to 6 times per day (every 4 hours).

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum Napellus 15X HPUS

Ferrum Phosphoricum 12X HPUS

Hepar Sulphuris Calcareum 12X HPUS

Phosphorus 9X HPUS

Spongia Tosta 12X HPUS

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

Purpose

OTC - PURPOSE SECTION

sore throat

sore throat

sore throat

pain in throat

sore throat

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves sore throat symptoms in children, including:
  • occasional minor irritation 
  • pain

Warnings

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

Do not use more than directed

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).

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.

SPL UNCLASSIFIED SECTION

In case of emergency or accidental overdose, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 up to 6 times per day (every 4 hours).

Children 6 years

to under 12 years

10 mL up to 6 times per day (every 4 hours).

Adults and children

12 years and over

15 mL up to 6 times per day (every 4 hours).

Other information

OTHER SAFETY INFORMATION

  • Do not use if imprinted "SEALED FOR YOUR PROTECTION" tamper-evident bottle cap band is broken or missing.
  • The inner packaged bottle is child-resistant.
  • Store at room temperature.
  • Do not refrigerate.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Glycerine, Glycyrrhiza Extract, Natural Grape Flavor, Purified Water, Sodium Benzoate.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

SPL UNCLASSIFIED SECTION

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.

Principal Display Panel - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

NDC 54973-4020-1

2-12

YEARS

NEW

4 KIDS

SINCE 1903

Hyland's

Sore

Throat*

Relieves minor

sore throat pain

and irritation

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

NATURAL

GRAPE

FLAVOR

4 FL. OZ (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54973-40204 KIDS SORE THROAT GRAPE (SPONGIA OFFICINALIS SKELETON, ROASTED, ACONITUM NAPELLUS, PHOSPHORUS, CALCIUM SULFIDE AND FERROSOFERRIC PHOSPHATE) LIQUID [HYLAND'S INC.]2Legacy NDC20221124_a0c3adb0-e7a3-2ba3-e053-2a95a90ac79e.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-402054973-4020-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM SULFIDE1MBW07J51QACTIB
PHOSPHORUS27YLU75U4WACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
SPONGIA OFFICINALIS SKELETON, ROASTED1PIP394IIDACTIB
GLYCYRRHIZA GLABRA2788Z9758HIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
FERROSOFERRIC PHOSPHATE91GQH8I5F7ACTIB

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
41b26e2d-d7cd-5aaa-e063-6394a90ae8e1a0c3adb0-e7a3-2ba3-e053-2a95a90ac79e2025-10-21WarningsExact identifier
spl set id: a0c3adb0-e7a3-2ba3-e053-2a95a90ac79e

Reported adverse events (FAERS/openFDA)#

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