NDC Code(s) : 0363-0640-08
Packager : Walgreen Company

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cold and Flu Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0640
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE(UNII: 9D2RTI9KYH)
(DEXTROMETHORPHAN - UNII:7355X3ROTS) 		DEXTROMETHORPHAN HYDROBROMIDE10 mg
GUAIFENESIN(UNII: 495W7451VQ)
(GUAIFENESIN - UNII:495W7451VQ) 		GUAIFENESIN200 mg
PHENYLEPHRINE HYDROCHLORIDE(UNII: 04JA59TNSJ)
(PHENYLEPHRINE - UNII:1WS297W6MV) 		PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color orange Score no score
Shape OVAL Size 19 mm
Flavor Imprint Code 44;640
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:0363-0640-082 in 1 CARTON 27/02/2014
112 in 1 BLISTER PACK Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 02/27/2014

LABELER - Walgreen Company(008965063)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(0363-0640), pack(0363-0640)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(0363-0640)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(0363-0640)

PRINCIPAL DISPLAY PANEL

Walgreens
 Compare to the active ingredients in
Vicks® DayQuil® Severe Cold & Flu††
• WALGREENS •
PHARMACIST RECOMMENDED†

NDC 0363-0640-08

DAY

Severe
Cold & Flu

ACETAMINOPHEN 325 mg / PAIN RELIEVER / FEVER REDUCER
DEXTROMETHORPHAN HBr 10 mg / COUGH SUPPRESSANT
GUAIFENESIN 200 mg / EXPECTORANT
PHENYLEPHRINE HCI 5 mg / NASAL DECONGESTANT

Maximum Strength

• Relieves headache, fever, sore throat, minor aches & pains,
chest congestion, thins & loosens mucus, nasal
congestion, sinus pressure & cough

24
CAPLETS

ACTUAL SIZE

TAMPER EVIDENT:
DO NOT USE IF
PACKAGE IS OPENED OR IF
BLISTER UNIT IS
TORN, BROKEN
OR SHOWS ANY SIGNS
OF TAMPERING

†Our pharmacists recommend the
Walgreens brand. We invite you to
compare to national brands.
††This product is not manufactured or
distributed by The Procter & Gamble
Company, owner of the registered
trademark Vicks® DayQuil® Severe Cold
& Flu.

50844 REV0722A64008

DISTRIBUTED BY: WALGREEN CO.
200 WILMOT RD., DEERFIELD, IL 60015
100% SATISFACTION GUARANTEED
walgreens.com   
©2021 Walgreen Co.

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Walgreens 44-640Walgreens 44-640