4 KIDS COMPLETE ALLERGY DAYTIME- sodium chloride, aconitum napellus, luffa operculata fruit, euphrasia stricta,galphimia glauca flowering top, histamine dihydrochloride,onion,anemone pulsatilla and schoennocaulon officinale seed liquid

4 Kids Complete Allergy Daytime by

Drug Labeling and Warnings

4 Kids Complete Allergy Daytime 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 6X HPUS

Allium Cepa 6X HPUS

Euphrasia Officinalis 6X HPUS

Galphimia Glauca 12X HPUS

Histaminum Hydrochloricum 12X HPUS

Luffa Operculata 12X HPUS

Natrum Muriaticum 6X HPUS

Pulsatilla 6X HPUS

Sabadilla 6X HPUS

“HPUS” indicates that the active ingredients are in the

official Homeopathic Pharmacopœia of the United States.

Purpose

Aconitum Napellus 6X HPUS ....itchy throat, sneezing

Allium Cepa 6X HPUS ..runny nose, watery/itchy eyes

Euphrasia Officinalis 6X HPUS...........nasal discharge

Galphimia Glauca 12X HPUS .... sneezing, runny nose

Histaminum Hydrochloricum 12X HPUS ... itchy nose

Luffa Operculata 12X HPUS .......sinus pain, headache

Natrum Muriaticum 6X HPUS ....... itchy/burning eyes

Pulsatilla 6X HPUS.............................. sinus pressure

Sabadilla 6X HPUS ................. uncontrollable sneezing

Uses

Temporarily relieves the symptoms of indoor and outdoor allergens, including: itchy nose or throat itchy watery or burning eyes runny nose sneezing headache sinus pain or pressure

Warnings

Do not use

to treat food allergies.

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

Consult a physician if

symptoms persist for more than 7 days or worsen.

Keep this and all medications out of the reach of children

In case of accidental overdose, contact a medical professional or Poison Control Center immediately.

Do not use if imprinted tamper-evident bottle cap band is broken or missing

The inner packaged bottle is child-resistant

In case of emergency

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.

Drug Facts (continued)

Directions

Measure only with the dosing cup provided

Do not use dosing cup with other products

On dosing cup, mL = milliliter, tsp = teaspoon

• Children 2 years to under 6 years: 5 mL or 1 tsp up to

  6 times per day (every 4 hours)

• Children 6 years to under 12 years:

  10 mL or 2 tsp up to

  6 times per day (every 4 hours)

• Adults and children 12 years and over:

  15 mL or 3 tsp up to

  6 times per day (every 4 hours)

Inactive ingredients

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

Questions or comments?

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 4 FL. OZ. (118 mL) Bottle Carton

NDC: 54973-3382-1

HOMEOPATHIC

Ages

2-12

NATURAL

RELIEF

SINCE 1903

Hyland's

4 Kids

Complete

Allergy*

DAYTIME

Itchy Nose & Throat

Watery Eyes

Runny Nose

Sneezing

ALCOHOL FREE

SUGAR FREE

DYE FRE

4 FL. OZ. (118 mL)

INGREDIENTS AND APPEARANCE

4 KIDS COMPLETE ALLERGY DAYTIME 
sodium chloride, aconitum napellus, luffa operculata fruit, euphrasia stricta,galphimia glauca flowering top, histamine dihydrochloride,onion,anemone pulsatilla and schoennocaulon officinale seed liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54973-3382
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	6 [hp_X]  in 1 mL
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	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
SCHOENOCAULON OFFICINALE SEED (UNII: 6NAF1689IO) (SCHOENOCAULON OFFICINALE SEED - UNII:6NAF1689IO)	SCHOENOCAULON OFFICINALE SEED	6 [hp_X]  in 1 mL
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	6 [hp_X]  in 1 mL
ANEMONE PULSATILLA (UNII: I76KB35JEV) (ANEMONE PULSATILLA - UNII:I76KB35JEV)	ANEMONE PULSATILLA	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54973-3382-1	1 in 1 CARTON	11/01/2018
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		11/01/2018

Labeler - Hyland's Inc. (028570695)

Establishment
Name	Address	ID/FEI	Business Operations
Standard Homeopathic Company		008316655	manufacture(54973-3382)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources		622559110	manufacture(54973-3382) , pack(54973-3382) , label(54973-3382)