NDC Code(s) : 56062-308-62
Packager : Publix Super Markets Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

severe cold Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride TABLET, FILM COATED
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:56062-308
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
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
CARNAUBA WAX(UNII: R12CBM0EIZ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE(UNII: 68401960MK)
MALTODEXTRIN(UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYVINYL ALCOHOL(UNII: 532B59J990)
POVIDONES(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS(UNII: 3WJQ0SDW1A)
Product Characteristics
Color YELLOW Score no score
Shape OVAL (capsule shaped) Size 20 mm
Flavor VANILLA Imprint Code L234
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:56062-308-622 in 1 CARTON
112 in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 02/26/2009

PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS AND DIRECTIONS

MULTI-SYMPTOM

severe cold

ACETAMINOPHEN – FEVER/HEADACHE/SORE THROAT

PHENYLEPHRINE HCl – NASAL CONGESTION

DEXTROMETHORPHAN HBr – COUGHING

GUAIFENESIN – CHEST CONGESTION

pain reliever/fever reducer

nasal decongestant

cough suppressant

expectorant

ACTUAL SIZE

24 CAPLETS

Compare to the Active Ingredients in Tylenol® Cold Multi-Symptom Severe Cool Burst®

Publix Severe Cold 1.jpgPublix Severe Cold 1.jpg