OBREDON (Page 10 of 10)

Principal Display Panel-16 fl oz. Bottle

Principal Display Panel -- 16 fl oz. Bottle Label
(click image for full-size original)

16 fl oz. Bottle Label

NDC -58716-433-16

OBREDON (hydrocodone bitartrate and guaifenesin) oral solution CII
2.5 mg/ 200 mg per 5 mL

Contains:

Hydrocodone Bitartrate … 2.5 mg/5 mL
WARNING: May be habit forming.

Guaifenesin ………………… 200 mg/5 mL

Rx Only

16 fl oz. (473 mL)

USUAL DOSAGE: See Package Insert for Complete Dosage Recommendations.
Dispense in a tight, light-resistant container with a child-resistant closure.

WARNING: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]

Tamper evident by foil seal under cap. Do not use if foil seal is broken or missing.

Manufactured by:
Sovereign Pharmaceuticals, LLC 06/2018

OBREDON hydrocodone bitartrate and guaifenesin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58716-433
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 2.5 mg in 5 mL
GUAIFENESIN (GUAIFENESIN) GUAIFENESIN 200 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
METHYLPARABEN
POTASSIUM CITRATE
POTASSIUM SORBATE
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SACCHARIN SODIUM
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58716-433-16 473 mL in 1 BOTTLE None
2 NDC:58716-433-04 118 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205474 12/30/2014
Labeler — Sovereign Pharmaceuticals, LLC (623168267)

Revised: 12/2018 Sovereign Pharmaceuticals, LLC

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