NDC Code(s) : 55312-235-06
Packager : Western Family Foods, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Mucus Relief Cold and Sinus Mucinex Cold and Sinus Maximum Strength LIQUID
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55312-235
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ) 		GUAIFENESIN400 mg in 20 mL
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN650 mg in 20 mL
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE10 mg in 20 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN(UNII: PDC6A3C0OX)
XANTHAN GUM(UNII: TTV12P4NEE)
WATER(UNII: 059QF0KO0R)
DISODIUM EDTA-COPPER(UNII: 6V475AX06U)
PROPYL GALLATE(UNII: 8D4SNN7V92)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SUCRALOSE(UNII: 96K6UQ3ZD4)
SORBITOL(UNII: 506T60A25R)
SODIUM CITRATE(UNII: 1Q73Q2JULR)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
CITRIC ACID ACETATE(UNII: DSO12WL7AU)
Product Characteristics
Color Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55312-235-06177 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product29/10/2013
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 10/29/2013 04/30/2018

PRINCIPAL DISPLAY PANEL

Maximum Strength Mucus Relief Cold and Sinus

Acetaminophen, Aches and Fever

Guaifenesin, Chest Congestion and Mucus

Phenylephrine HCI Stuffy Nose

For Ages 12 and Over

compare to the active ingredients

of Mucinex Fast Max

Cold & Sinus Maximum Strength

Proudly distributed by Western Family Foods, Inc.

PO Box 4057

Portland, OR 97208 U.S.A.

Copyright 2013 Marca Registrada

www.westernfamily.com

6 FL OZ 177 mL

PRINCIPAL DISPLAY PANEL

Guaifenesin, Acetaminophen, Phenylephrine HCIWESTERN FAMILY Mucus Relief Cold and Sinus Maximum Strength