GREEN TUSSIN DM- guaifenesin, dextromethorphan hbr liquid 
Green Choice for Life

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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Active Ingredients (in each 15 mL)

Dextromethorphan HBr 10mg.............Cough Suppressant

Guaifenesin 100mg.........................................Expectorant

Cough Suppressant

Expectorant

Uses

Warnings

Do not exceed recommended dosage.

A persistent cough may be a sign of a serious condition. If cough persists for more than one week, tends to recur, or is accompanied by fever, rash or persistent head ache, consult a doctor.

Do not use

If pregnant or breast-feeding, ask health professional before use.

Incase of accidental overdose, get medical help or contact a Poison Control Center right away.

Keep out of reach of children.

adults & children 12 Years of age or more.............2 tablespoonfuls (30mL) every 4 hours

children under 12 years of age..............................consult your doctor

Other information

Inactive Ingredients  aloe, ascorbic acid, caramel color, cat's claw extract, corn syrup, ethyl alcohol, eucalyptus oil, garlic FE, ginger root FE, honey, menthol, methyl paraben, onion FE, peppermint spirits, potassium sorbate, propylene glycol, propyl paraben, sodium benzoate, sucralose

Questions? call 305-763-3228 M-F 9 am to 5 pm Eastern

Green Tussin DM label

GREEN TUSSIN  DM
guaifenesin, dextromethorphan hbr liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55287-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) Guaifenesin100 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
ALOE (UNII: V5VD430YW9)  
GINGER (UNII: C5529G5JPQ)  
CAT'S CLAW (UNII: 9060PRM18Q)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
PEPPERMINT (UNII: V95R5KMY2B)  
MENTHOL (UNII: L7T10EIP3A)  
ONION (UNII: 492225Q21H)  
GARLIC (UNII: V1V998DC17)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
CARAMEL (UNII: T9D99G2B1R)  
HONEY (UNII: Y9H1V576FH)  
CORN SYRUP (UNII: 9G5L16BK6N)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55287-100-061 in 1 CARTON08/26/2013
1180 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/21/2012
Labeler - Green Choice for Life (828750526)
Registrant - Green Choice for Life (828750526)
Establishment
NameAddressID/FEIBusiness Operations
All Pharma LLC117605075MANUFACTURE(55287-100)

Revised: 8/2013
Document Id: e0b7eae1-d858-4c6b-bc9c-116b6d9d28ce
Set id: cad2d826-2cee-4e2c-9f81-918a6476b365
Version: 2
Effective Time: 20130809
 
Green Choice for Life