Naprosyn (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Delivers 5 mL

NDC 0121-0899-05

Naproxen Oral Suspension USP

125 mg/5 mL

PRINCIPAL DISPLAY PANEL
					 NDC – 71511-701-16
				Naprosyn
				(naproxen suspension)
				125 mg/5 mL (contains 39 mg sodium)
				473 mL Bottle
				Rx Only
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

Delivers 10 mL

NDC 0121-1798-10

Naproxen Oral Suspension USP

250 mg/10 mL

image description
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Delivers 20 mL

NDC 0121-2697-20

Naproxen Oral Suspension USP

500 mg/20 mL

image description
(click image for full-size original)
NAPROSYN naproxen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-0899(NDC:71511-701)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 125 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
MAGNESIUM ALUMINUM SILICATE
SORBITOL
SODIUM CHLORIDE
METHYLPARABEN
FUMARIC ACID
FD&C YELLOW NO. 6
PINEAPPLE
ORANGE
WATER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-0899-20 2 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-0899-20) and contains a CUP, UNIT-DOSE (0121-0899-05)
1 NDC:0121-0899-05 5 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-0899-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018965 01/01/2018
NAPROSYN naproxen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-1798
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 250 mg in 10 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
MAGNESIUM ALUMINUM SILICATE
SORBITOL
SODIUM CHLORIDE
METHYLPARABEN
FUMARIC ACID
FD&C YELLOW NO. 6
PINEAPPLE
ORANGE
WATER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-1798-20 2 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-1798-20) and contains a CUP, UNIT-DOSE (0121-1798-10)
1 NDC:0121-1798-10 10 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-1798-20)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018965 01/01/2018
NAPROSYN naproxen suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0121-2697
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NAPROXEN (NAPROXEN) NAPROXEN 500 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
MAGNESIUM ALUMINUM SILICATE
SORBITOL
SODIUM CHLORIDE
METHYLPARABEN
FUMARIC ACID
FD&C YELLOW NO. 6
PINEAPPLE
ORANGE
WATER
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0121-2697-22 10 TRAY in 1 CASE contains a TRAY
1 10 CUP, UNIT-DOSE in 1 TRAY This package is contained within the CASE (0121-2697-22) and contains a CUP, UNIT-DOSE (0121-2697-20)
1 NDC:0121-2697-20 20 mL in 1 CUP, UNIT-DOSE This package is contained within a TRAY and a CASE (0121-2697-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018965 01/01/2018
Labeler — Pharmaceutical Associates, Inc. (044940096)
Registrant — Pharmaceutical Associates, Inc. (097630693)
Establishment
Name Address ID/FEI Operations
Pharmaceutical Associates, Inc. 097630693 repack (0121-0899), label (0121-0899), repack (0121-1798), label (0121-1798), repack (0121-2697), label (0121-2697)
Establishment
Name Address ID/FEI Operations
Entreprises Importfab, Inc. 248586117 manufacture (0121-0899), manufacture (0121-1798), manufacture (0121-2697)

Revised: 12/2020 Pharmaceutical Associates, Inc.

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