4KIDS COMPLETE COLD N FLU

Manufacturer
Hyland's | Standard Homeopathic Company
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:57:35

Label at a glance#

Product4KIDS COMPLETE COLD N FLU
Active ingredientCAIRINA MOSCHATA HEART/LIVER AUTOLYSATE, BRYONIA ALBA ROOT, EUPATORIUM PERFOLIATUM FLOWERING TOP, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM IODIDE
Label structure8 sections

Indications and uses

Temporarily relieves the symptoms of the common cold and flu including body aches and headaches, cough and congestion, fever, chills, and sore throat.

Dosage and administration

Children 2 years to under 6 years dissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Children 6 years to under 12 years dissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required Adults and children 12 years and over dissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved;...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopœia of the United States.
Anas Barbariae Hepatis Et Cordis Extractum 200C HPUSearly onset flu symptoms
Bryonia 6X HPUSbody aches, headaches, cough
Eupatorium Perfoliatum 6X HPUSbody aches, headaches, cough
Euphrasia Officinalis 6X HPUSrunny nose, cough, fever, chills, congestion
Gelsemium Sempervirens 6X HPUSaches and pain, fever, fatigue
Kali Iodatum 3X HPUSheadache, runny nose, fever, sore throat

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the symptoms of the common cold and flu including body aches and headaches, cough and congestion, fever, chills, and sore throat.

Warnings

WARNINGS SECTION

OTC - ASK DOCTOR SECTION

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
  • Inflammation, fever or infection develops
  • Symptoms are accompanied by high fever (101°F)
  • Cough tends to recur or is accompanied by high fever, rash or persistent headache

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

OTC - DO NOT USE SECTION

Do not use this product for persistent or chronic cough such as asthma, smoking or emphysema or if cough is accompanied by excessive mucus, unless directed by a licensed health care professional.

SPL UNCLASSIFIED SECTION

A persistent cough may be a sign of a serious condition.

Sore throat warning

SPL UNCLASSIFIED SECTION

Severe or persistent sore throat or sore throat accompanied by high fever, headache, nausea, and vomiting may be serious. Consult a doctor promptly.

OTC - DO NOT USE SECTION

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

SPL UNCLASSIFIED SECTION

There have been no reports of interactions between this product and ibuprofen or acetaminophen.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

Children 2 years to under 6 yearsdissolve 2 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
Children 6 years to under 12 yearsdissolve 3 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required
Adults and children 12 years and overdissolve 4 tablets under tongue every 15 minutes for up to 8 doses until relieved; then every 4 hours as required

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia Gum, Lactose N.F.

Questions or comments?

OTC - QUESTIONS SECTION

(800) 624-9659

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-3241-1
HOMEOPATHIC*

Natural
Relief

Ages
2-12

SINCE 1903
Hyland's

4Kids
Complete
Cold 'n Flu

Body Aches & Headache

Cough & Congestion

Fever & Chills

Sore Throat

125
QUICK-DISSOLVING
TABLETS

SAFE &
EFFECTIVE

PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton
PRINCIPAL DISPLAY PANEL - 125 Tablet Bottle Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BRYONIA ALBA ROOTACTIVE INGREDIENTT7J046YI2B1
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATEACTIVE INGREDIENTRN2HC612GY1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE INGREDIENT1W0775VX6E1
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL1
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q1
POTASSIUM IODIDEACTIVE INGREDIENT1C4QK22F9J1
BRYONIA ALBA ROOTACTIVE MOIETYT7J046YI2B1
CAIRINA MOSCHATA HEART/LIVER AUTOLYSATEACTIVE MOIETYRN2HC612GY1
EUPATORIUM PERFOLIATUM FLOWERING TOPACTIVE MOIETY1W0775VX6E1
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL1
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q1
IODIDE IONACTIVE MOIETY09G4I6V86Q1
ACACIAINACTIVE INGREDIENT5C5403N26O1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-324154973-3241-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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 1 · 55 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY193.8 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / BUCCAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, CHEWABLE / ORAL1412 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OGUM, CHEWING / BUCCAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / ORAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / VAGINAL430 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER / RESPIRATORY (INHALATION)90 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OLOZENGE / ORAL108 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, COATED / ORAL156 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GFILM, EXTENDED RELEASE / TRANSDERMAL675 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED / ORAL590 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EFFERVESCENT / ORAL96.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCREAM / VAGINAL3 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR133 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCONCENTRATE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GOINTMENT / TOPICALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, ORALLY DISINTEGRATING / ORAL7 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, FILM COATED, EXTENDED RELEASE / ORAL620 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OSYRUP / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, COATED / ORAL332.05 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / SUBLINGUAL9.1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / SUBLINGUAL352 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, SOLUTION / INTRAVENOUS0.45 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER / ORAL800 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, DELAYED RELEASE / ORAL30 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, EXTENDED RELEASE / ORAL400 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, EXTENDED RELEASE / ORAL120 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / RECTAL20 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SUSPENSION / ORAL7386 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, FILM COATED / ORAL0.14 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, EXTENDED RELEASE / ORAL34.4 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OCAPSULE / ORAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
ACACIAACACIA5C5403N26OPOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / ORAL1682 mg/15mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, DELAYED RELEASE / ORAL231.84 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAVENOUS203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / BUCCAL296.7 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GGRANULE, FOR SUSPENSION / ORAL512.5 mg/5mlExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSOLUTION / RECTAL8 %w/vExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GSUPPOSITORY / VAGINALNAExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OSUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION / INTRAMUSCULAR203.5 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET, DELAYED RELEASE / ORAL160 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS133 mgExact identifier — unii candidate
36 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET, CHEWABLE / ORAL121 mgExact identifier — unii candidate
19 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE, COATED PELLETS / ORAL135.2 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / ORAL530 mgExact identifier — unii candidate
36 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GCAPSULE / RESPIRATORY (INHALATION)44.4 mgExact identifier — unii candidate
36 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
d39df898-56c9-0f5b-e053-2995a90a28e151595bcb-41b7-4a31-95be-6f2286047ada2021-12-20WarningsExact identifier
spl set id: 51595bcb-41b7-4a31-95be-6f2286047ada

Reported adverse events (FAERS/openFDA)#

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