PEDIATRIC COUGH AND COLD MEDICINE- chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Pediatric Cough and Cold Medicine by

Drug Labeling and Warnings

Pediatric Cough and Cold Medicine by is a Otc medication manufactured, distributed, or labeled by Lannett Company, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Chlorpheniramine maleate 1 mg (in each 5 mL)

Active Ingredient: Pseudoephedrine hydrochloride 15 mg (in each 5 mL)

Active Ingredient: Dextromethorphan hydrobromide 5 mg (in each 5 mL)

PURPOSE

Purpose of Chlorpheniramine maleate: Antihistamine

Purpose of Pseudoephedrine hydrochloride: Nasal Decongestant

Purpose of Dextromethorphan hydrobromide: Cough Suppressant

INDICATIONS & USAGE

Uses temporarily relieves common cold, hay fever or other upper respiratory allergy symptoms:

• nasal congestion
  
• runny nose
  
• sneezing
  
• cough

Warnings

Do not exceed recommended dosage.

Do not give this product to a child who is taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions), or for 2 weeks after stopping the MAOI drug. If you are uncertain whether your child’s prescription drug contains an MAOI, ask a doctor or pharmacist before giving this product.

Ask a doctor before use if your child has

• heart diseases
  
• high blood pressure
  
• thyroid disease
  
• diabetes
  
• glaucoma
  
• asthma
  
• a breathing problem or a persistent or chronic cough
  
• excessive phlegm (mucus)
  
• cough that occurs with too much phlegm (mucus)
  
• chronic bronchitis

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

When using this product your child may

• become easily excited
  
• get drowsy
  
• sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

• nervousness, dizziness or sleeplessness occur
  
• symptoms do not improve within 7 days or are accompanied by fever
  
• cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
  

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 4 to 6 hours or as directed by a doctor
  
• Do not exceed 4 doses in 24 - hour period.

• AGE: DOSE
• Children 6 to under 11 years: 2 teaspoonfuls (TSP)
• Children under 6 years: DO NOT USE

Other information

Store at room temperature 20°-25°C (68°-77°F). Do not use if tamper-evident band around cap is broken or missing.

Inactive ingredients

citric acid, FD&C red no. 40, wild cherry flavor, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate, sorbitol.

Questions

888-974-5279

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PEDIATRIC COUGH AND COLD MEDICINE 
chlorpheniramine maleate and pseudoephedrine hydrochloride and dextromethorphan hydrobromide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54838-115
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
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F)	PSEUDOEPHEDRINE HYDROCHLORIDE	15 mg  in 5 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	5 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	CHERRY (wild cherry flavor)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54838-115-40	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/05/1997

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	01/05/1997

Labeler - Lannett Company, Inc. (161630033)