Safetussin PM

Dosage form: liquid
Ingredients: Dextromethorphan 7.5mg in 5mL, DOXYLAMINE SUCCINATE 3.125mg in 5mL
Labeler: Kramer Laboratories
NDC Code: 55505-173

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

Doxylamine Succinate

Antihistamine


Cough Suppressant

Keep out of reach of children. In case of
overdose, get medical help or contact a Poison
Control Center right away

Temporarily relieves cold symptoms:
•Cough
•Runny nose and sneezing

Do not exceed 4 doses per 24 hours.
adults and children
12 years and over
children 4 to 12 years
children under 4 years
4 teaspoons
every 6 hours
Ask a doctor


 aspartame
benzoic acid
citric acid
glycerin
menthol
methylparaben
natural peppermint flavor
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 prescription drug contains an
MAOI, ask a doctor or pharmacist before taking
this product.•To make a child sleep

SAFETUSSIN   PM
dextromethorphan doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55505-173
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dextromethorphan (Dextromethorphan) Dextromethorphan7.5 mg  in 5 mL
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE 3.125 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
Aspartame 
benzoic acid  
CITRIC ACID MONOHYDRATE  
glycerin  
menthol 
methylparaben 
MINT 
propylene glycol 
propylparaben 
water 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:55505-173-33120 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34112/01/2010
Labeler - Kramer Laboratories (122720675)
Establishment
NameAddressID/FEIOperations
Denison 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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