ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated 
TIME CAP LABS 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.

----------

341R TCL 49483 341 Acetaminophen 500 mg 100ct 500ct

DRUG FACTS

Active ingredient (in each caplet)
Acetaminophen 500 mg

Purpose
Pain reliever/fever reducer

Uses

headache
the common cold
backache
minor pain of arthritis
toothache
muscular aches
premenstrual and menstrual cramps

Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take:

Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

Ask a doctor before use if you have liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

Stop using and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions: do not take more than directed
adults and children 12 years and over:

children under 12 years: ask a doctor

OTHER INFORMATION

Other information

hypromellose, mineral oil, povidone, pregelatinized starch, sodium starch glycloate*, stearic acid, titanium dioxide
* may contain this ingredient

341R-Acetaminophen 500mg tablets-ct500-bottle label100 CT

ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-341
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL ((caplet)) Size17mm
FlavorImprint Code TCL341
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-341-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/17/2018
2NDC:49483-341-50500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/20/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/18/2011
Labeler - TIME CAP LABS INC (037052099)
Registrant - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS INC037052099manufacture(49483-341)

Revised: 5/2021
Document Id: c2981825-a34e-1250-e053-2995a90a8894
Set id: fd24d0e0-4f36-42d3-9149-2fb957690305
Version: 4
Effective Time: 20210518
 
TIME CAP LABS INC