CHILDREN COUGH AND COLD- chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl liquid

Children Cough and Cold by

Drug Labeling and Warnings

Children Cough and Cold by is a Otc medication manufactured, distributed, or labeled by RUGBY LABORATORIES. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient (in each 10 mL)

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Pseudoephedrine HCl 30 mg

PURPOSE

Purpose

Antihistamine

Cough Suppressant

Nasal Decongenstant

INDICATIONS & USAGE

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

Warnings

Do not use in a child who is takin 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 on MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if child has

• diabetes
• glaucoma
• thyroid disease
• heart diseae
• 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 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 sign of a serious condition. 
• Symptoms do not get better within 7 days or occur with fever

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C red #40, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

QUESTIONS

Questions or comments? 1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CHILDREN COUGH AND COLD 
chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1243
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg  in 10 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	30 mg  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SUCRALOSE (UNII: 96K6UQ3ZD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1243-97	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/01/2019

Labeler - RUGBY LABORATORIES (079246066)