SAFETUSSIN PM- dextromethorphan doxylamine succinate liquid

Safetussin by

Drug Labeling and Warnings

Safetussin by is a Otc medication manufactured, distributed, or labeled by Kramer Laboratories, Denison Pharmecuticals. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Dextromethorphan

Doxylamine Succinate

PURPOSE

Cough Suppressant


Antihistamine

KEEP OUT OF REACH OF CHILDREN

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

INDICATIONS & USAGE

• temporarily relieves coughgh runny nose and sneezing

DOSAGE & ADMINISTRATION

Do not take more than 4 doses in any 24- hours period.
adults and children12 years and over 4 teaspoons every 6 hours
children 4 to 12 years ask a doctor
children under 4 years do not use

INACTIVE INGREDIENT

 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. to make a child sleep.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFETUSSIN   PM
dextromethorphan doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-190
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg  in 5 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	3.125 mg  in 5 mL

Inactive Ingredients
Ingredient Name	Strength
Aspartame (UNII: Z0H242BBR1)
benzoic acid (UNII: 8SKN0B0MIM)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
glycerin (UNII: PDC6A3C0OX)
menthol (UNII: L7T10EIP3A)
methylparaben (UNII: A2I8C7HI9T)
MINT (UNII: FV98Z8GITP)
propylene glycol (UNII: 6DC9Q167V3)
propylparaben (UNII: Z8IX2SC1OH)
water (UNII: 059QF0KO0R)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-190-36	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	07/01/2015

Labeler - Kramer Laboratories (122720675)

Establishment
Name	Address	ID/FEI	Business Operations
Denison Pharmecuticals		001207208	manufacture(55505-190)