ACETAMINOPHEN EXTRA STRENGTH- acetaminophen tablet, film coated 
NCS HealthCare of KY, LLC dba Vangard Labs

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Acetaminophen Caplets 500mg 8409 Time-Cap

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

 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 warning)

adults and children 12 years and over

children under 12 years

ask a doctor

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

Manufactured by:

Time-Cap Labs, Inc

7 Michael Avenue

Farmingdale, NY 11735

341R 0922

PRINCIPAL DISPLAY PANEL - BINGO CARD

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - UNIT DOSE

PRINCIPAL DISPLAY PANEL
ACETAMINOPHEN  EXTRA STRENGTH
acetaminophen tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0615-8409(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:0615-8409-3930 in 1 BLISTER PACK; Type 0: Not a Combination Product10/05/2021
2NDC:0615-8409-306 in 1 BOX, UNIT-DOSE10/06/2021
25 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01307/18/2011
Labeler - NCS HealthCare of KY, LLC dba Vangard Labs (050052943)
Establishment
NameAddressID/FEIBusiness Operations
NCS HealthCare of KY, LLC dba Vangard Labs050052943repack(0615-8409)

Revised: 11/2023
Document Id: 9b225569-29ee-47e6-9303-c90b3620258a
Set id: 7fae4caf-a8aa-442e-97ee-0465577bdb87
Version: 10
Effective Time: 20231117
 
NCS HealthCare of KY, LLC dba Vangard Labs