NDC Code(s) : 67091-135-50
Packager : WinCo Foods, LLC

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acetaminophen Easy Tabs Acetaminophen TABLET, COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67091-135
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
FD&C RED NO. 40(UNII: WZB9127XOA)
ALUMINUM OXIDE(UNII: LMI26O6933)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
HYPROMELLOSES(UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE(UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN(UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN(UNII: AG9B65PV6B)
STEARIC ACID(UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color red Score no score
Shape ROUND Size 11 mm
Flavor Imprint Code A92
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:67091-135-501 in 1 CARTON 15/12/2014
150 in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 12/15/2014

LABELER - WinCo Foods, LLC(056098817)

PRINCIPAL DISPLAY PANEL

WinCo® Foods

*Compare to the active ingredient in TYLENOL® Extra Strength Coated Tablets

EXTRA STRENGTH

Acetaminophen

Coated Tablets

Sweet Coated

For Adults

ACETAMINOPHEN / PAIN RELIEVER - FEVER REDUCER

50 Tablets

500 mg EACH

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