Safetussin CD

Dosage form: liquid
Ingredients: Dextromethorphan Hydrobromide 30mg in 10mL, PHENYLEPHRINE HYDROCHLORIDE 5mg in 10mL
Labeler: Kramer Laboratories
NDC Code: 55505-141

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.

Dextromethorphan HBr 30 mg

Phenylephrine HCl 5 mg

Cough suppressant

Nasal decongestant

In case of overdose, get medical help or contact a Poison Control Center right away

temporarily relieves cough due to minor throat and bronchial irratation
helps rid bronchial passage of phlegm (mucus)
relieves nasal congestion

take every 6 hours, not more than 4 doses in 24 hours

12 years and over 2 teaspoons

6 to 12 years 1 teaspoon

under 6 years do not use


citric acid, glycerin, menthol, methylparaban, natural orange flavor, potassium benzoate, propylene glycol,propylparaben,purified water

Do not use  
if you are now 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.

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SAFETUSSIN  CD
dextromethorpan hydrobromide phenylephrine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-141
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan Hydrobromide (Dextromethorphan) Dextromethorphan Hydrobromide30 mg  in 10 mL
PHENYLEPHRINE HYDROCHLORIDE (PHENYLEPHRINE) PHENYLEPHRINE HYDROCHLORIDE5 mg  in 10 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
glycerin 
methylparaben 
ORANGE 
POTASSIUM BENZOATE 
propylene glycol 
propylparaben 
WATER  
MENTHOL 
Product Characteristics
Color    Score    
ShapeSize
FlavorORANGEImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-141-33120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/08/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIOperations
Dension Pharmecuticals001207208manufacture

Revised: 12/2010
 
Kramer Laboratories

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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