KIDKARE COUGH/COLD- chlorpheniramine, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid

Kidkare by

Drug Labeling and Warnings

Kidkare by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each 2 TSP (10 mL))	Purposes
Chlorpheniramine maleate, USP 2 mg	Antihistamine
Dextromethorphan HBr, USP 10 mg	Cough suppressant
Pseudoephedrine HCl, USP 30 mg	Nasal 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.

AGE	DOSE
Children 6 to 11 years	2 TSP
Children under 6 years	Do 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

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

KIDKARE  COUGH/COLD
chlorpheniramine, dextromethorphan hydrobromide, and pseudoephedrine hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-2310
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	1 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	red (Reddish)	Score
Shape		Size
Flavor	CHERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-2310-97	1 in 1 CARTON	01/13/2011	09/30/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	01/13/2011	09/30/2020

Labeler - Rugby Laboratories, Inc. (079246066)