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

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341R TCL 49483 341 Extra Strength Acetaminophen 500 mg

DRUG FACTS

Active ingredient (in each caplet)
Acetaminophen 500 mg

Purpose
Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

temporarily reduces fever

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

• more than 4,000 mg of acetaminophen in 24 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
• skin reddening
• blisters
• rash
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

These could be signs of a serious condition.

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

Keep out of reach of children.

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick 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 (see overdose waning)
adults and children 12 years and over:

• take 2 caplets every 6 hours while symptoms last
• do not take more than 6 caplets 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: ask a doctor

OTHER INFORMATION

Other information

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

Questions or comments?Call 1-877-290-4008

341R-Timely-APAP500-200s-label341R-Timely-APAP-500s-label341R-Timely-Acetaminophen 500mg-bottle label-1000s341R-Timely-Acetaminophen 500mg-bottle label-100s

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
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)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
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
3NDC:49483-341-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/20/2022
4NDC:49483-341-20200 in 1 BOTTLE; Type 0: Not a Combination Product10/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/18/2011
Labeler - TIME CAP LABS INC (037052099)
Registrant - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS INC037052099manufacture(49483-341)

Revised: 10/2023
Document Id: 08aca495-24f0-9caa-e063-6294a90a4096
Set id: fd24d0e0-4f36-42d3-9149-2fb957690305
Version: 8
Effective Time: 20231027
 
TIME CAP LABS INC