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

Complete Allergy 4 Kids by

Drug Labeling and Warnings

Complete Allergy 4 Kids by is a Homeopathic medication manufactured, distributed, or labeled by Hyland's, Inc., Standard Homeopathic Company, Lifetech Resources. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

• 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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/01/2010

Labeler - Hyland's, Inc. (028570695)

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

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