FDA.reportPublic FDA data

4 KIDS PAIN RELIEF GRAPE

Manufacturer
Hyland's Inc. | Applied Laboratories Inc.
Effective date
2022-11-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:46:31

Label at a glance#

Product4 KIDS PAIN RELIEF GRAPE
Active ingredientPHOSPHORUS, ANEMONE PULSATILLA, TOXICODENDRON PUBESCENS LEAF, ARNICA MONTANA, BRYONIA ALBA ROOT, ACONITUM NAPELLUS, GELSEMIUM SEMPERVIRENS ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP
Label structure9 sections

Indications and uses

Temporarily relieves minor pain symptoms in children, including: muscle aches  toothache  headache cramps  stiffness  back pain pain in joints or limbs

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 every 15 minutes for 4 doses, then every 4 hours until relieved. Children 6 years to under 12 years 10 mL every 15 minutes for 4 doses, then every 4 hours until relieved. Adults and children 12 years and over 15 mL every 15 minutes for...

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Aconitum Napellus 30X HPUS

Arnica Montana 30X HPUS

Bryonia Alba 30X HPUS

Eupatorium Perfoliatum 30X HPUS

Gelsemium Sempervirens 12X HPUS

Phosphorus 12X HPUS

Pulsatilla 9X HPUS

Rhus Toxicodendron 12X HPUS

"HPUS" indicates that the active ingredients are in the

official Homeopathic Pharmacopoeia of the United States.

Purpose

OTC - PURPOSE SECTION

headache, back pain,minor pain in joints

muscle aches, pain

back pain, minor pain in joints

pain in back and limbs

muscle aches/pain, headache

minor pain in joints, headache

toothache, minor pain in joints

stiffness, minor pain in joints, cramps

Uses

INDICATIONS & USAGE SECTION

  • Temporarily relieves minor pain symptoms in children, including:
  • muscle aches 
  • toothache 
  • headache
  • cramps 
  • stiffness 
  • back pain
  • pain in joints or limbs

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 48 hours 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

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 every 15 minutes for

4 doses, then every 4 hours until relieved.

Children 6 years

to under 12 years

10 mL every 15 minutes for

4 doses, then every 4 hours until relieved.

Adults and children

12 years and over

15 mL every 15 minutes for

4 doses, then every 4 hours until relieved.

Drug Facts (continued)

SPL UNCLASSIFIED SECTION

Other information

SPL UNCLASSIFIED SECTION

  • 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 54973-4018-1

2-12

YEARS

NEW

4 KIDS

SINCE 1903

Hyland's

Pain

Relief*

Relieves muscle aches,

headache, minor joint

pain and toothache

NO ACETAMINOPHEN

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

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-401854973-4018-1, 54973-4018-2, 54973-4018-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ARNICA MONTANAO80TY208ZWACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
ACONITUM NAPELLUSU0NQ8555JDACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
EUPATORIUM PERFOLIATUM FLOWERING TOP1W0775VX6EACTIB

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
32d993c1-c055-cbc1-e063-6394a90a8ff69f6e17e6-7556-08ff-e053-2a95a90abdfd2025-04-15WarningsExact identifier
spl set id: 9f6e17e6-7556-08ff-e053-2a95a90abdfd

Reported adverse events (FAERS/openFDA)#

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