FDA.reportPublic FDA data

Complete Allergy 4 Kids

Manufacturer
Hyland's, Inc. | Standard Homeopathic Company | Lifetech Resources
Effective date
2021-07-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:41:12

Label at a glance#

ProductComplete Allergy 4 Kids
Active ingredientACONITUM NAPELLUS, ONION, EUPHRASIA STRICTA, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PULSATILLA VULGARIS, SCHOENOCAULON OFFICINALE SEED
Label structure8 sections

Indications and 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.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Aconitum Napellus 6X HPUSitchy throat, sneezing
Allium Cepa 6X HPUShay fever, runny nose, watery, itchy eyes
Euphrasia 6X HPUSnasal inflammation, nasal discharge
Galphimia Glauca 12X HPUSsneezing, runny nose
Histaminum Hydrochloricum 12X HPUSear pain
Luffa Operculata 12X HPUSsinus pain, headache
Natrum Muriaticum 6X HPUSear pain, itchy, burning eyes

Nux Vomica 6X HPUS

(0.0000016% Alkaloids, calculated) 		itchy nose
Pulsatilla 6X HPUSsinus pressure
Sabadilla 6X HPUShay fever, uncontrollable sneezing

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

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use to treat food allergies.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - ASK DOCTOR SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

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

In case of emergency

SPL UNCLASSIFIED SECTION

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)

SPL UNCLASSIFIED SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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)

CartonCarton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACONITUM NAPELLUSACTIVE INGREDIENTU0NQ8555JD3
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL3
GALPHIMIA GLAUCA FLOWERING TOPACTIVE INGREDIENT93PH5Q8M7E3
HISTAMINE DIHYDROCHLORIDEACTIVE INGREDIENT3POA0Q644U3
LUFFA OPERCULATA FRUITACTIVE INGREDIENTC4MO6809HU3
ONIONACTIVE INGREDIENT492225Q21H3
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV3
SCHOENOCAULON OFFICINALE SEEDACTIVE INGREDIENT6NAF1689IO3
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X3
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139193
ACONITUM NAPELLUSACTIVE MOIETYU0NQ8555JD3
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL3
GALPHIMIA GLAUCA FLOWERING TOPACTIVE MOIETY93PH5Q8M7E3
HISTAMINEACTIVE MOIETY820484N8I33
LUFFA OPERCULATA FRUITACTIVE MOIETYC4MO6809HU3
ONIONACTIVE MOIETY492225Q21H3
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV3
SCHOENOCAULON OFFICINALE SEEDACTIVE MOIETY6NAF1689IO3
SODIUM CATIONACTIVE MOIETYLYR4M0NH373
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139193
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
GLYCYRRHIZA GLABRAINACTIVE INGREDIENT2788Z9758H3
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-309754973-3097-1, 54973-3097-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
GLYCERINPDC6A3C0OXIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ONION492225Q21HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GALPHIMIA GLAUCA FLOWERING TOP93PH5Q8M7EACTIB
HISTAMINE DIHYDROCHLORIDE3POA0Q644UACTIB
LUFFA OPERCULATA FRUITC4MO6809HUACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SCHOENOCAULON OFFICINALE SEED6NAF1689IOACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 198 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / NASAL2.8 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / SOFT TISSUEADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / RESPIRATORY (INHALATION)0.13 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE, EFFERVESCENT / ORAL60 mgExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUPASTE / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / SUBCUTANEOUS26 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAVENOUS2068 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING / ORAL83 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / RESPIRATORY (INHALATION)8 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, COATED / ORAL0.2 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRATHECALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUELIXIR / ORAL5.02 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / BUCCALNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPFILM / SUBLINGUAL10 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUINJECTION, EMULSION / INTRAVENOUS0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / IONTOPHORESIS0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINHALANT / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAMUSCULAR0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / TOPICAL17 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUGRANULE / ORALNAExact identifier — unii candidate
35 equally ranked IID candidates

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
d43ce101-69a8-1275-e053-2a95a90a2bb7d79010d4-a917-44bd-b987-ad06d523db662021-12-28WarningsExact identifier
spl set id: d79010d4-a917-44bd-b987-ad06d523db66

Reported adverse events (FAERS/openFDA)#

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