NDC Code(s) : 11822-5031-8
Packager : Rite Aid Corporation

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:11822-5031
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)
D&C YELLOW NO. 10 ALUMINUM LAKE(UNII: CQ3XH3DET6)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
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)
SUCRALOSE(UNII: 96K6UQ3ZD4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color yellow Score no score
Shape OVAL Size 19 mm
Flavor MENTHOL Imprint Code 44;503
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11822-5031-82 in 1 CARTON 08/04/2005
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 08/04/2005

LABELER - Rite Aid Corporation(014578892)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(11822-5031), pack(11822-5031)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(11822-5031)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(11822-5031)

PRINCIPAL DISPLAY PANEL

NDC 11822-5031-8

Compare to the active ingredients in 
Tylenol® COLD + FLU SEVERE*

SEVERE
COLD & FLU

ACETAMINOPHEN 325 mg
DEXTROMETHORPHAN HBr 10 mg
GUAIFENESIN 200 mg
PHENYLEPHRINE HCl 5 mg

PAIN RELIEVER / FEVER REDUCER • COUGH SUPPRESSANT 
EXPECTORANT • NASAL DECONGESTANT

Relieves headache, fever, sore throat,
nasal congestion, cough, mucus,
chest congestion

COOL BLAST
FLAVOR

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

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the registered
trademark Tylenol® COLD + FLU SEVERE.
50844           REV0922E50308

PARENTS:
Learn about teen medicine abuse
www.StopMedicineAbuse.org

DISTRIBUTED BY:
RITE AID
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com

SATISFACTION GUARANTEE
if you're not satisfied, we'll 
happily refund your money.

Rite Aid 44-503ARite Aid 44-503A