NDC Code(s) : 46994-935-15
Packager : SAVE-A-LOT FOOD STORES, LTD.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Acetaminophen Acetaminophen, Diphenhydramine HCl TABLET, FILM COATED
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:46994-935
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN(UNII: 362O9ITL9D)
(ACETAMINOPHEN - UNII:362O9ITL9D) 		ACETAMINOPHEN500 mg
DIPHENHYDRAMINE HYDROCHLORIDE(UNII: TC2D6JAD40)
(DIPHENHYDRAMINE - UNII:8GTS82S83M) 		DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
STARCH, CORN(UNII: O8232NY3SJ)
CROSCARMELLOSE SODIUM(UNII: M28OL1HH48)
FD&C BLUE NO. 1 ALUMINUM LAKE(UNII: J9EQA3S2JM)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED(UNII: 532B59J990)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
STEARIC ACID(UNII: 4ELV7Z65AP)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Product Characteristics
Color blue Score no score
Shape OVAL Size 17 mm
Flavor Imprint Code 44;235
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:46994-935-151 in 1 CARTON 15/05/1994
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 05/15/1994

LABELER - SAVE-A-LOT FOOD STORES, LTD.(095484572)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 038154464 pack(46994-935)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867837 manufacture(46994-935), pack(46994-935)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 832867894 manufacture(46994-935)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 868734088 manufacture(46994-935)

Establishment
Name Address ID/FEI Business Operations
LNK International, Inc. 967626305 pack(46994-935)

PRINCIPAL DISPLAY PANEL

being
well®

Compare to EXTRA STRENGTH
TYLENOL® PM active ingredients*

EXTRA STRENGTH
Acetaminophen PM
Caplets, 500 mg / Diphenhydramine HCl, 25 mg
Pain Reliever / Nighttime Sleep-Aid

Non-Habit
Forming

50
Caplets

Actual Size

TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured or distributed by
Johnson & Johnson Corporation, owner of the
registered trademark Extra Strength Tylenol® PM.

50844    REV0521G23515

DISTRIBUTED BY:
SAVE A LOT LTD.
ST. ANN, MO 63074
savealot.com

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Being Well 44-235Being Well 44-235