ACETAMINOPHEN- acetaminophen tablet, film coated 
TIME CAP LABORATORIES, INC

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 APAP

Active Ingredient: Each tablet contains Acetaminophen 500 mg

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


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

342LABEL

ACETAMINOPHEN 
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-342
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorredScoreno score
ShapeROUNDSize11mm
FlavorImprint Code TCL342
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-342-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
2NDC:49483-342-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
3NDC:49483-342-00100000 in 1 CARTON; Type 0: Not a Combination Product12/17/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/01/2012
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABORATORIES, INC037052099manufacture(49483-342)

Revised: 12/2018
Document Id: 7d3e2e18-1dee-4000-e053-2a91aa0aeefe
Set id: 2569383a-4a05-4ddb-852e-b37e487ffcde
Version: 2
Effective Time: 20181217
 
TIME CAP LABORATORIES, INC