KIDKARE COUGH/COLD- chlorpheniramine, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid 
Rugby Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Rugby ® Kid Kare

Drug Facts

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

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

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.

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

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

When using this product

  • 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

  • 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

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

Directions

  • 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

store at 20°-25° C (68°-77° F)

Inactive ingredients

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

Questions or comments?

1-800-645-2158

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

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
KIDKARE  COUGH/COLD
chlorpheniramine, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-2310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE5 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE15 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
WATER (UNII: 059QF0KO0R)  
CHERRY (UNII: BUC5I9595W)  
Product Characteristics
Colorred (Reddish) Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-2310-971 in 1 CARTON01/13/201109/30/2020
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/13/201109/30/2020
Labeler - Rugby Laboratories, Inc. (079246066)

Revised: 9/2019
 
Rugby Laboratories, Inc.