Dexamethasone (Page 3 of 3)

Dexamethasone suppression tests

  1. Tests for Cushing’s syndrome. Give 1 mg of Dexamethasone orally at 11:00 p.m. Blood is drawn for plasma cortisol determination at 8:00 a.m. the following morning. For greater accuracy, give 0.5 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.
  2. Test to distinguish Cushing’s syndrome due to pituitary ACTH excess from Cushing’s syndrome due to other causes. Give 2 mg of Dexamethasone orally every 6 hours for 48 hours. Twenty-four hour urine collections are made for determination of 17-hydroxycorticosteroid excretion.

HOW SUPPLIED

DEXAMETHASONE ELIXIR 0.5 mg/5 mL is supplied as a clear, red, raspberry-flavored liquid in the following sizes:

100 mL fill in a 4 fl oz bottle with separately packaged dropper assembly. Dropper graduated for 0.125 mg and 0.25 mg.

8 fl oz (No Dropper) (237 mL) (NDC 60432-466-08)

RECOMMENDED STORAGE

Store at controlled room temperature, 15 ° to 30°C (59° to 86°F).

KEEP TIGHTLY CLOSED

AVOID FREEZING

Dispense in a tight container as defined in the USP.

Rx Only

Product No.: 8466

Manufactured By: Morton Grove Pharmaceuticals, Inc.

Morton Grove, IL 60053

A50-8466-08 REV. 07-18

PRINCIPAL DISPLAY PANEL Bottle Label

MGP

NDC 60432-466-08

DEXAMETHASONE

ELIXIR, USP

0.5 mg/5 mL

DO NOT USE IF TAMPER-EVIDENT

SEAL IS BROKEN OR MISSING.

Rx Only

NET: 8 fl oz (237 mL)

Dexamethasone Elixir Label
(click image for full-size original)

Dexamethasone Elixir Label

DEXAMETHASONE dexamethasone elixir
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:60432-466
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 0.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
SUCROSE
PROPYLENE GLYCOL
BENZOIC ACID
ALCOHOL
WATER
ANHYDROUS CITRIC ACID
FD&C RED NO. 40
TRISODIUM CITRATE DIHYDRATE
Product Characteristics
Color RED Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60432-466-08 1 BOTTLE, GLASS in 1 BOX contains a BOTTLE, GLASS
1 237 mL in 1 BOTTLE, GLASS This package is contained within the BOX (60432-466-08)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088254 07/27/1983
Labeler — Morton Grove Pharmaceuticals, Inc. (801897505)
Registrant — Morton Grove Pharmaceuticals, Inc. (801897505)
Establishment
Name Address ID/FEI Operations
Morton Grove Pharmaceuticals, Inc. 801897505 ANALYSIS (60432-466), LABEL (60432-466), MANUFACTURE (60432-466), PACK (60432-466)

Revised: 12/2018 Morton Grove Pharmaceuticals, Inc.

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