COMPLETE ALLERGY 4 KIDS- aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquid
Hyland's, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Hyland's 4 Kids Complete Allergy

Drug Facts

Active Ingredients	Purpose
Aconitum Napellus 6X HPUS	itchy throat, sneezing
Allium Cepa 6X HPUS	hay fever, runny nose, watery, itchy eyes
Euphrasia 6X HPUS	nasal inflammation, nasal discharge
Galphimia Glauca 12X HPUS	sneezing, runny nose
Histaminum Hydrochloricum 12X HPUS	ear pain
Luffa Operculata 12X HPUS	sinus pain, headache
Natrum Muriaticum 6X HPUS	ear pain, itchy, burning eyes
Nux Vomica 6X HPUS (0.0000016% Alkaloids, calculated)	itchy nose
Pulsatilla 6X HPUS	sinus pressure
Sabadilla 6X HPUS	hay fever, uncontrollable sneezing

“HPUS” indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Uses

Temporarily relieves the symptoms of indoor and outdoor allergens including runny nose, itchy, watery eyes, itchy nose and throat, stuffy nose and facial pain.

Warnings

Do not use to treat food allergies.

As with any drug, ask a doctor before use if pregnant or nursing.

Consult a physician if symptoms persist for more than 7 days or worsen.

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

Do not use if imprinted tamper band is broken or missing.

In case of emergency

Contact a medical professional or Poison Control Center immediately. Hyland's may be contacted for emergency information about our products 24 hours a day, 7 days per week at (800) 624-9659

Drug Facts (continued)

Directions

Measure only with the dosing cup provided
Do not use dosing cup with other products
On dosing cup, tsp = teaspoon

Children ages 2-under 6 years: 5 mL or 1 teaspoon up to 6 times per day (every 4 hours).

Children 6 to under 12 years: 10 mL or 2 teaspoons up to 6 times per day (every 4 hours).

Adults and children 12 years and over: 15 mL or 3 teaspoons up to 6 times per day (every 4 hours)

Inactive Ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

Natural
Relief

NDC 54973-3097-1
HOMEOPATHIC*

Ages
2-12

SINCE 1903
Hyland's®

4 Kids

Complete
Allergy *

Itchy Nose & Throat

Itchy, Watery Eyes

Runny Nose

Sneezing

ALCOHOL FREE
SUGAR FREE
DYE FREE

SAFE &
EFFECTIVE

4 FL. OZ. (118 mL)

Carton

COMPLETE ALLERGY 4 KIDS
aconitum napellus, onion, euphrasia stricta, galphimia glauca flowering top, histamine dihydrochloride, luffa operculata fruit, sodium chloride, strychnos nux-vomica seed, pulsatilla vulgaris, and schoenocaulon officinale seed liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54973-3097
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	6 [hp_X] in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X] in 1 mL
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	6 [hp_X] in 1 mL
GALPHIMIA GLAUCA FLOWERING TOP (UNII: 93PH5Q8M7E) (GALPHIMIA GLAUCA FLOWERING TOP - UNII:93PH5Q8M7E)	GALPHIMIA GLAUCA FLOWERING TOP	12 [hp_X] in 1 mL
HISTAMINE DIHYDROCHLORIDE (UNII: 3POA0Q644U) (HISTAMINE - UNII:820484N8I3)	HISTAMINE DIHYDROCHLORIDE	12 [hp_X] in 1 mL
LUFFA OPERCULATA FRUIT (UNII: C4MO6809HU) (LUFFA OPERCULATA FRUIT - UNII:C4MO6809HU)	LUFFA OPERCULATA FRUIT	12 [hp_X] in 1 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	6 [hp_X] in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X] in 1 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	6 [hp_X] in 1 mL
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X] in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:54973-3097-1	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010
2	NDC:54973-3097-2	19.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2010

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/01/2010	12/28/2021

Labeler - Hyland's, Inc. (028570695)

Name	Address	ID/FEI	Business Operations
Establishment
Standard Homeopathic Company		008316655	manufacture(54973-3097)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources		622559110	pack(54973-3097) , manufacture(54973-3097)

Revised: 12/2021

Document Id: d43ce101-69a8-1275-e053-2a95a90a2bb7

Set id: d79010d4-a917-44bd-b987-ad06d523db66

Version: 7

Effective Time: 20211228

Hyland's, Inc.