QDOLO (Page 12 of 12)

PRINCIPAL DISPLAY PANEL — QDOLO (tramadol hydrochloride) 5 mg/mL, 16 oz Bottle Label

NDC 71511-301-16

QDOLO (tramadol hydrochloride) 5 mg/mL (equivalent to tramadol 4.4 mg per 1 mL) CIV

Keep out of reach of children.

Rx only

16 oz. (473 mL)

PRINCIPAL DISPLAY PANEL -- 5 mg/mL, 16 oz. Bottle Label
(click image for full-size original)
QDOLO tramadol hydrochloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71511-301
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAMADOL HYDROCHLORIDE (TRAMADOL) TRAMADOL HYDROCHLORIDE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
GLYCERIN
PROPYLENE GLYCOL
SODIUM BENZOATE
TRISODIUM CITRATE DIHYDRATE
SUCRALOSE
WATER
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:71511-301-16 473 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA214044 09/11/2020
Labeler — Athena Bioscience, LLC (080710928)
Establishment
Name Address ID/FEI Operations
Sovereign Pharmaceuticals, LLC 623168267 manufacture (71511-301)

Revised: 12/2023 Athena Bioscience, LLC

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