NDC Code(s) : 13551-101-05, 13551-101-01
Packager : Avadel Pharmaceuticals (USA), Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Karbinal Carbinoxamine Maleate SUSPENSION, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:13551-101
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbinoxamine Maleate(UNII: 02O55696WH)
(Carbinoxamine - UNII:982A7M02H5) 		Carbinoxamine Maleate4 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Polysorbate 80(UNII: 6OZP39ZG8H)
Sodium Metabisulfite(UNII: 4VON5FNS3C)
Glycerin(UNII: PDC6A3C0OX)
Methylparaben(UNII: A2I8C7HI9T)
Propylparaben(UNII: Z8IX2SC1OH)
Xanthan Gum(UNII: TTV12P4NEE)
Anhydrous Citric Acid(UNII: XF417D3PSL)
High Fructose Corn Syrup(UNII: XY6UN3QB6S)
Sucrose(UNII: C151H8M554)
Povidones(UNII: FZ989GH94E)
Sodium Polystyrene Sulfonate(UNII: 1699G8679Z)
Triacetin(UNII: XHX3C3X673)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:13551-101-05480 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2014
2NDC:13551-101-012 in 1 CARTON 01/03/2014
230 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product01/03/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022556 01/03/2014

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 480 mL Bottle Label

NDC 13551-101-05

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

480 mL Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 480 mL Alternate Bottle Label

NDC 13551-101-05

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

480 mL Alternate Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

NDC 13551-101-01

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
1 fl oz (30 mL)

Physician Sample Not For Sale

30 mL Bottle Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 mL Carton Label

NDC 13551-101-01

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
Two 1 fl oz (30 mL)

PHYSICIAN SAMPLES - NOT FOR SALE

30 mL Carton Label

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 480 mL Alternate Bottle Label (FSC Laboratories)

NDC 13551-101-05

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx only
16 fl oz (480 mL)

480 mL Alternate Bottle Label (FSC Laboratories)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 30 mL Alternate Carton Label (FSC Laboratories)

NDC 13551-101-01

Karbinal ™ ER
(carbinoxamine maleate)
Extended-release
Oral Suspension
4 mg/5 mL

Shake Well Before Use

Dose every 12 hours

Dispense with an accurate milliliter measuring device

Strawberry Banana Flavored

Rx Only
Two 1 fl oz (30 mL)

Physician Samples - Not for Sale

30 mL Alternate Carton Label (FSC Laboratories)