SAFETUSSIN DM- dextromethorpan guaifenesin 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 HBr, USP 10 mg

Guaifenesin, USP 100 mg

PURPOSE

Cough suppressant

Expectorant

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 cough due to minor throat and bronchial irritation  
loosen phlegm (mucus)
helps rid bronchial passages of phlegm (mucus)

DOSAGE & ADMINISTRATION

do not take more than 6 doses in any 24-hour period
this adult product is not intended for use in children under 12 years of age

Adults and children 12 years and over 2 teaspoons every 4 hours
children under 12 years do not use

INACTIVE INGREDIENT

aspartame ,benzoic acid, citric acid, glycerin,methol,methylparaben,nautral pepermint 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 use if you have
cough that occurs with too much phlegm (mucus)
cough that lasts or is chronic such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and 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 a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFETUSSIN  DM
dextromethorpan guaifenesin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55505-189
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dextromethorphan Hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS)	Dextromethorphan Hydrobromide	10 mg  in 5 mL
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	100 mg  in 5 mL

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

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55505-189-36	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(55505-189)