Kidkare

Manufacturer
Rugby Laboratories, Inc.
Effective date
2019-09-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:09:45

Label at a glance#

ProductKidkare cough/cold
Active ingredientCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PSEUDOEPHEDRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies: cough runny nose nasal congestion sneezing itching of the nose or throat itchy, watery eyes

Dosage and administration

dose may be repeated every 6 hours. do not exceed 4 doses in a 24-hour period use enclosed dosage cup only. Do not use any other device. AGE DOSE Children 6 to 11 years 2 TSP Children under 6 years Do not use

Storage and handling

store at 20°-25° C (68°-77° F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each 2 TSP (10 mL))Purposes
Chlorpheniramine maleate, USP 2 mgAntihistamine
Dextromethorphan HBr, USP 10 mgCough suppressant
Pseudoephedrine HCl, USP 30 mgNasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves these symptoms of the common cold, hay fever or other upper respiratory allergies:

  • cough
  • runny nose
  • nasal congestion
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

Do not use in a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your child's prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if child has

  • diabetes
  • glaucoma
  • thyroid disease
  • heart disease
  • high blood pressure
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem such as chronic bronchitis
  • chronic cough that lasts such as occurs with asthma

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • drowsiness may occur
  • sedatives and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the child gets nervous, dizzy or sleepless
  • cough lasts more than 7 days, comes back or occurs with fever, rash or persistent headache. A persistent cough may be a sign of a serious condition.
  • symptoms do not get better within 7 days or occur with fever

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • dose may be repeated every 6 hours.
  • do not exceed 4 doses in a 24-hour period
  • use enclosed dosage cup only. Do not use any other device.
AGEDOSE
Children 6 to 11 years2 TSP
Children under 6 yearsDo not use

Other information

STORAGE AND HANDLING SECTION

store at 20°-25° C (68°-77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

artificial cherry flavor, citric acid, FD&C red #40, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol solution

Questions or comments?

OTC - QUESTIONS SECTION

1-800-645-2158

SPL UNCLASSIFIED SECTION

Distributed by:
Rugby Laboratories
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Rugby®

NDC 0536-2310-97

Cherry Flavored
Alcohol Free

Kid
Kare

Antihistamine
Cough Suppressant
Nasal Decongestant

Children's
Cough/Cold
Liquid

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-2310-97ML - Milliliter0536-231099d52e82-2cf1-4739-80af-abeccc1c285812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ChlorpheniramineACTIVE INGREDIENT3U6IO1965U1
Dextromethorphan HydrobromideACTIVE INGREDIENT9D2RTI9KYH1
Pseudoephedrine HydrochlorideACTIVE INGREDIENT6V9V2RYJ8N1
ChlorpheniramineACTIVE MOIETY3U6IO1965U1
DextromethorphanACTIVE MOIETY7355X3ROTS1
PseudoephedrineACTIVE MOIETY7CUC9DDI9F1
Anhydrous Trisodium CitrateINACTIVE INGREDIENTRS7A450LGA1
CherryINACTIVE INGREDIENTBUC5I9595W1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QP1
FD&C Red no. 40INACTIVE INGREDIENTWZB9127XOA1
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Propylene glycolINACTIVE INGREDIENT6DC9Q167V31
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EU1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-23100536-2310-97

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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 6 · 339 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / ORAL315 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE, EXTENDED RELEASE / ORAL101 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUGEL / DENTAL0.08 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRALESIONALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
Anhydrous Trisodium CitrateANHYDROUS TRISODIUM CITRATERS7A450LGAINJECTION / INTRAMUSCULAR792 mgExact identifier — unii candidate
30 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, EXTENDED RELEASE / ORAL45 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Anhydrous Trisodium CitrateANHYDROUS TRISODIUM CITRATERS7A450LGAPOWDER, FOR SOLUTION / ORAL48 mg/5mlExact identifier — unii candidate
30 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / SUBLINGUAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
CherryCHERRYBUC5I9595WTABLET / ORAL0.45 mgExact identifier — unii candidate
2 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUCREAM / TOPICAL0.2 %w/wExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii candidate
28 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / OPHTHALMICADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
Anhydrous Trisodium CitrateANHYDROUS TRISODIUM CITRATERS7A450LGASOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
30 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUINJECTION, SOLUTION / INTRAMUSCULAR4.8 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSPONGE / TOPICALNAExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR38 mgExact identifier — unii candidate
88 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C Red no. 40FD&C RED NO. 40WZB9127XOAGUM, CHEWING / BUCCAL48 mgExact identifier — unii candidate
28 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUSOLUTION / TOPICAL0.1 %w/vExact identifier — unii candidate
35 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPCAPSULE / ORAL238 mgExact identifier — unii candidate
88 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCAPSULE, EXTENDED RELEASE / ORAL265 mgExact identifier — unii candidate
75 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Sodium BenzoateSODIUM BENZOATEOJ245FE5EUPASTE / ORAL28 mgExact identifier — unii candidate
35 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
Citric Acid MonohydrateCITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
Propylene glycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 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
93640944-8e90-d456-e053-2995a90ac9fe63fdf19e-f467-4873-8cbf-da2e5e2cdc0b2019-09-25WarningsExact identifier
spl id: 93640944-8e90-d456-e053-2995a90ac9fe
spl set id: 63fdf19e-f467-4873-8cbf-da2e5e2cdc0b

Reported adverse events (FAERS/openFDA)#

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