SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid 
Denison Pharmaceuticals, LLC.

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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SAFETUSSIN PM

ACTIVE INGREDIENT

Active ingredients (in each 5ml tsp)Purpose
Dextromethorphan HBr,USP 7.5 mgCough Suppressant
Doxylamine Succinate, USP 3.125 mg Expectorant

USES

Cough Suppressant


Antihistamine

Keep out of reach of children

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

INDICATIONS & USAGE

DOSAGE & ADMINISTRATION

agedose
adults and children
12 years and over
4 teaspoons
every 6 hours
children 4 to 12 yearsask a doctor
children under 4 yearsdo not use


 aspartame,benzoic acid,citric acid,glycerin,menthol,methylparaben,natural peppermint flavor,propylene glycol,propylparaben
 purified water

WARNINGS

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. 

Ask a Doctor

Before you use if you have:

ASK DOCTOR/PHARMACIST

If you are taking sedatives or tranquilizers.

WHEN USING

STOP USE

Ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of serious conditions.

OTHER INFORMATION

Safe this package for complete information

SAFETUSSIN PM (DEXTROMETHORPHAN DOXYLAMINE SUCCINATE) LIQUID

label

SAFETUSSIN  PM
dextromethorphan doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-5307
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE7.5 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE3.125 mg  in 5 mL
Inactive Ingredients
Ingredient NameStrength
ASPARTAME (UNII: Z0H242BBR1)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINT (UNII: FV98Z8GITP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0295-5307-171 in 1 CARTON01/01/2017
1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:0295-5307-281 in 1 CARTON01/01/201711/07/2019
2240 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2017
Labeler - Denison Pharmaceuticals, LLC. (001207208)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC.001207208manufacture(0295-5307)

Revised: 11/2019
Document Id: 96c516e4-fdf3-07ae-e053-2a95a90ac5b0
Set id: 3d6e56ad-d31b-4ef6-9690-f18b1ee45664
Version: 2
Effective Time: 20191107
 
Denison Pharmaceuticals, LLC.