Hydromet (Page 10 of 10)

PRINCIPAL DISPLAY PANEL

Rx Only

NDC 0472-1030 -16

Hydromet Oral Solution CII

Hydrocodone Bitartrate and Homatropine Methylbromide Oral Solution

5 mg and 1.5 mg/5 mL

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

One Pint (473 mL)

image
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HYDROMET hydrocodone bitartrate and homatropine methylbromide solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0472-1030
Route of Administration ORAL DEA Schedule CII
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HYDROCODONE BITARTRATE (HYDROCODONE) HYDROCODONE BITARTRATE 5 mg in 5 mL
HOMATROPINE METHYLBROMIDE (METHYLHOMATROPINE) HOMATROPINE METHYLBROMIDE 1.5 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
CHERRY
ANHYDROUS CITRIC ACID
D&C RED NO. 33
FD&C BLUE NO. 1
FD&C RED NO. 40
METHYLPARABEN
PROPYLENE GLYCOL
WATER
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE
SUCROSE
Product Characteristics
Color RED Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0472-1030-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088017 09/30/2002
Labeler — Actavis Pharma, Inc. (119723554)

Revised: 08/2020 Actavis Pharma, Inc.

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