4 KIDS PAIN RELIEF- anemone pulsatilla, toxicodendron pubescens leaf, gelsemium sempervirens root, phosphorus, eupatorium perfoliatum flowering top, bryonia alba root, arnica montana and aconitum napellus liquid

4 KIDS PAIN RELIEF by

Drug Labeling and Warnings

4 KIDS PAIN RELIEF by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

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

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

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

Warnings

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

Do notuse more than directed.

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).

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

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

• 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)

Other 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

Citric Acid, Glycerine, Glycyrrhiza Extract, Purified Water, Sodium Benzoate.

Questions or comments?

(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

HOMEOPATHIC

NDC: 54973-4015-1

2-12

YEARS

NEW

4 KIDS

SINCE 1903

Hylnand's

Pain

Relief*

Relieves muscles aches,

headache, minor joint

pain and toothache

NO ACETAMINOPHEN

NO ALCOHOL or PARABENS

NO SUGAR or DYES

NATURAL

RELIEF

4 FL. OZ. (118 mL)

*SEE NOTE

ON SIDE PANEL

BELOW DRUG FACTS

INGREDIENTS AND APPEARANCE

4 KIDS PAIN RELIEF 
anemone pulsatilla, toxicodendron pubescens leaf, gelsemium sempervirens root, phosphorus, eupatorium perfoliatum flowering top, bryonia alba root, arnica montana and aconitum napellus liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-4015
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	30 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]  in 1 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	30 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]  in 1 mL
EUPATORIUM PERFOLIATUM FLOWERING TOP (UNII: 1W0775VX6E) (EUPATORIUM PERFOLIATUM FLOWERING TOP - UNII:1W0775VX6E)	EUPATORIUM PERFOLIATUM FLOWERING TOP	30 [hp_X]  in 1 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	12 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	12 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	9 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-4015-1	1 in 1 CARTON	01/27/2020
1		118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/27/2020

Labeler - Hyland's Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Applied Laboratories, Inc.		876754375	manufacture(54973-4015) , pack(54973-4015) , label(54973-4015)