Oseltamivir Phosphate (Page 9 of 9)

INSTRUCTIONS FOR USE

Oseltamivir Phosphate (oh” sel tam’ i vir fos’ fate) for oral suspension

How do I give a dose of oseltamivir phosphate for oral suspension?

Step 1. Shake the oseltamivir phosphate for oral suspension bottle well before each use.

Step 2. Open the bottle by pushing downward on the child resistant bottle cap and twisting it in the direction of the arrow.

Step 3. Measure the oral suspension with an appropriate oral dosing dispenser to be sure you get the correct dose. Contact your pharmacist if you do not have an appropriate oral dosing dispenser.

Step 4. Give the full contents of oral dosing dispenser directly into the mouth.

Step 5. Close the bottle with the child-resistant bottle cap after each use.

Step 6. Rinse oral dosing dispenser under running tap water and allow to air dry after each use.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

Mfg. Rev. 04-2018-01

AV 12/18 (P)

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

PRINCIPAL DISPLAY PANEL

567-60
(click image for full-size original)

OSELTAMIVIR PHOSPHATE oseltamivir phosphate for suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42291-567(NDC:69238-1273)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OSELTAMIVIR PHOSPHATE (OSELTAMIVIR ACID) OSELTAMIVIR ACID 6 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
MONOSODIUM CITRATE
SACCHARIN SODIUM
SODIUM BENZOATE
SORBITOL
TITANIUM DIOXIDE
XANTHAN GUM
Product Characteristics
Color white (white to off-white) Score
Shape Size
Flavor TUTTI FRUTTI Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42291-567-60 1 BOTTLE, GLASS in 1 CARTON contains a BOTTLE, GLASS
1 60 mL in 1 BOTTLE, GLASS This package is contained within the CARTON (42291-567-60)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210186 08/26/2019
Labeler — AvKARE, Inc (796560394)

Revised: 09/2019 AvKARE, Inc

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