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

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.

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Active ingredient (in each 10 mL)

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Pseudoephedrine HCl 30 mg

Purpose

Antihistamine

Cough Suppressant

Nasal Decongenstant

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

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

When using this product

Stop use and ask a doctor if

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.

Directions

 Age Dose
 Children 6 to 11 years 2 TSP
 Children under 6 years Do not use

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

Questions or comments? 1-800-645-2158

RugbyCough

CHILDREN COUGH AND COLD 
chlorpheniramine maleate, dextromethorphan hbr, pseudoephedrine hcl liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1243
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE2 mg  in 10 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 10 mL
PSEUDOEPHEDRINE HYDROCHLORIDE (UNII: 6V9V2RYJ8N) (PSEUDOEPHEDRINE - UNII:7CUC9DDI9F) PSEUDOEPHEDRINE HYDROCHLORIDE30 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1243-97118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/01/2019
Labeler - RUGBY LABORATORIES (079246066)

Revised: 3/2021
Document Id: c0401089-4a89-48cc-a6d2-fe4e3c26baf3
Set id: 6efe00ca-087c-44ae-843a-7db8999de066
Version: 2
Effective Time: 20210315
 
RUGBY LABORATORIES