NDC Code(s) : 63824-500-66, 63824-500-09, 63824-500-64
Packager : RB Health (US) LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE












Maximum Strength Mucinex Fast-Max Night Time Cold and FluAcetaminophen, Diphenhydramine Hydrochloride, and Phenylephrine Hydrochloride SOLUTION




Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-500
Route of Administration ORAL DEA Schedule




Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen(UNII: 362O9ITL9D)
(Acetaminophen - UNII:362O9ITL9D)
Acetaminophen 650 mg in 20 mL
Diphenhydramine Hydrochloride(UNII: TC2D6JAD40)
(Diphenhydramine - UNII:8GTS82S83M)
Diphenhydramine Hydrochloride 25 mg in 20 mL
Phenylephrine Hydrochloride(UNII: 04JA59TNSJ)
(Phenylephrine - UNII:1WS297W6MV)
Phenylephrine Hydrochloride 10 mg in 20 mL





Product Characteristics
Color BLUE Score
Shape

Size
Flavor FRUIT Imprint Code
Contains





Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63824-500-66 180 mL in 1 BOTTLE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 28/07/2018
2 NDC:63824-500-09 266 mL in 1 BOTTLE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 28/07/2018
3 NDC:63824-500-64 1 in 1 CARTON 10/01/2018
3 118 mL in 1 BOTTLE Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product) 28/07/2018




Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 03/15/2013

LABELER - RB Health (US) LLC(081049410)

PRINCIPAL DISPLAY PANEL

NDC 63824-500-64

MAXIMUM STRENGTH

Mucinex®
FAST-
MAX
®

NIGHT TIME COLD & FLU

Acetaminophen – Pain Reliever/Fever Reducer
Diphenhydramine HCl – Antihistamine/Cough Suppressant
Phenylephrine HCl – Nasal Decongestant

HEADACHE
BODY PAIN

SORE THROAT
FEVER

ITCHY THROAT
COUGH

ALL IN
ONE*

NASAL CONGESTION
SNEEZING
RUNNY NOSE

4 FL OZ (118 mL)
FOR AGES 12+

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton



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