ACETAMINOPHEN- acetaminophen tablet, film coated 
TARGET CORPORATION

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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342R TARGET - APAP 500 MG TABLETS - 11673-342

ACTIVE INGREDIENTS

Active Ingredient: Each tablet contains Acetaminophen 500 mg

INACTIVE INGREDIENTS

CARNAUBA WAX, FD-C RED NO. 40 ALUMINUM LAKE, HYPROMELLOSE, POLYETHYLENE GLYCOL(PEG) 400, POLYETHYLENE GLYCOL (peg) 8000, POVIDONE, PREGELATINIZED STARCH, SODIUM STARCH GLYCOLATE**, STEARIC ACID, SUCRALOSE, TITANIUM DIOXIDE

** MAY CONTAIN THIS INGREDIENT

PURPOSE: Pain Reliever - fever reducer

Keep Out of the Reach of Children: In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

Pain Reliever – temporarily relieves minor aches and pains due to: the common cold, headache, backache, muscular aches, toothache, premenstrual and menstrual cramps, minor pain of arthritis. Temporarily reduces fever.

Warnings;

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; 3 or more alcoholic drinks every day while using this product; with other drugs containing acetaminophen.

Overdose warning: Taking more than the recommended dose (0verdose) may cause liver damage. in case of overdose, get medical help or contact a Poison Control Center (1-800-222-1221) right way. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor

Children under 12 years: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage

24 CT

225 CT

100CT

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-342
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
POVIDONE (UNII: FZ989GH94E)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL342
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11673-342-4224 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
2NDC:11673-342-01100 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
3NDC:11673-342-26225 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/01/2019
Labeler - TARGET CORPORATION (006961700)
Registrant - TIME CAP LABORATORIES INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(11673-342)

Revised: 4/2019
Document Id: 87753c0d-af22-2f6a-e053-2a95a90a0b45
Set id: 80da2582-1a20-e111-e053-2991aa0acf32
Version: 2
Effective Time: 20190426
 
TARGET CORPORATION