Acetaminophen and codeine solution

Ingredients and appearance - Product information

Acetaminophen and codeine solution- Acetaminophen and codeine phosphate

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 0603-9013
Route of Administration Oral

Active Ingredient/Active Moiety

Ingredient Name Strength
Acetaminophen ( UNII: 362O9ITL9D)( Acetaminophen - UNII: 362O9ITL9D ) 120 mgin 5 mL
Codeine phosphate ( UNII: GSL05Y1MN6)( Codeine anhydrous - UNII: UX6OWY2V7J ) 12 mgin 5 mL

Inactive Ingredients

Ingredient Name Code
Alcohol ( UNII: 3K9958V90M)
Anhydrous citric acid ( UNII: XF417D3PSL)
Fd&c blue no. 1 ( UNII: H3R47K3TBD)
Fd&c yellow no. 6 ( UNII: H77VEI93A8)
High fructose corn syrup ( UNII: XY6UN3QB6S)
Methylparaben ( UNII: A2I8C7HI9T)
Polyethylene glycols ( UNII: 3WJQ0SDW1A)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Saccharin sodium ( UNII: SB8ZUX40TY)
Sodium citrate ( UNII: 1Q73Q2JULR)

Product Characteristics

Color ORANGE (orange-red) Flavor CHERRY

Packaging

# Item Code Package Description Marketing Start Date
1 NDC: 0603-9013-54 120mL in 1 BOTTLE 2011/11/10
2 NDC: 0603-9013-58 473mL in 1 BOTTLE 2011/11/10

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA091238 USA 2011/11/10

Labeler - Qualitest Pharmaceuticals( 011103059)

Establishment

Name ID/FEI Business Operations
Qualitest Pharmaceuticals 011103059 MANUFACTURE( 0603-9013)