NDC Code(s) : 49035-931-08
Packager : Wal-Mart Stores Inc

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Cold Multi-SymptomAcetaminophen, Chlorpheniramine maleate, Dextromethorphan HBr, Phenylephrine HCl KIT
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49035-931
Route of Administration DEA Schedule
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN(UNII: O8232NY3SJ)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
FD&C BLUE NO. 2 ALUMINUM LAKE(UNII: 4AQJ3LG584)
MAGNESIUM STEARATE(UNII: 70097M6I30)
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)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
CROSPOVIDONE, UNSPECIFIED(UNII: 2S7830E561)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STEARIC ACID(UNII: 4ELV7Z65AP)
SUCRALOSE(UNII: 96K6UQ3ZD4)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:49035-931-081 in 1 CARTON Type 0: Not a Combination Product21/07/2005
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M012 07/21/2005

LABELER - Wal-Mart Stores Inc(051957769)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(49035-931), pack(49035-931)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(49035-931)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 117025878 manufacture(49035-931)

PRINCIPAL DISPLAY PANEL

NDC 49035-931-08

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

  DayTime

Cold Multi-Symptom

 Acetaminophen,
 Dextromethorphan HBr,
 Phenylephrine HCl

Pain reliever/fever reducer
 Cough suppressant
nasal decongestant

Fever, headache, sore throat,
  nasal congestion, cough

 Pseudoephedrine Free

  12
 CAPLETS                  Actual Size

NightTime

Cold Multi-Symptom

Acetaminophen,
  Chlorpheniramine maleate
  Dextromethorphan HBr
  Phenylephrine HCl

Pain reliever/fever reducer
antihistamine
cough suppressant
nasal decongestant

Fever, headache, sore throat,
  runny nose, nasal congestion, cough

  Pseudoephedrine Free

12
CAPLETS                 Actual Size

50844    REV1122L47047308

Do Not Take The Daytime and Nighttime
Products at the Same Time.

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Equate 44-470C47308CEquate 44-470C47308C