ASPIRIN- aspirin tablet, coated 
TIME CAP LABS INC

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Aspirin 325 mg tablets

DRUG FACTS

Active ingredient (in each tablet)
Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

INDICATIONS AND USAGE

Uses

for the temporary relief of minor aches and pains due to

or as directed by your doctor

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include:

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you are

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:

pain gets worse or lasts more than 10 days

fever gets worse or lasts more than 3 days

redness or swelling is present in the painfull area

any new symptoms appear

ringing in the ears or a loss of hearing occurs

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may casue problems in the unborn child or complications during delivery.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

drink a full glass of water with each dose

Other information

Inactive ingredients corn starch, croscramellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

timely-aspirin325-300s11R-TCL-Aspirin 325 mg-bulk label11R-TCL-Aspirin 325 mg-bottle label-1000s11R-TCL-Aspirin 325 mg-bottle label-100s

ASPIRIN 
aspirin tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-011
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code TCL011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49483-011-101000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2014
2NDC:49483-011-01100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/02/2014
3NDC:49483-011-00100000 in 1 CARTON; Type 0: Not a Combination Product04/02/2014
4NDC:49483-011-31300 in 1 BOTTLE; Type 0: Not a Combination Product11/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01304/02/2014
Labeler - TIME CAP LABS INC (037052099)
Registrant - TIME CAP LABS INC (037052099)
Establishment
NameAddressID/FEIBusiness Operations
TIME CAP LABS INC037052099manufacture(49483-011)

Revised: 11/2023
Document Id: 0acac93d-0f05-0658-e063-6294a90a83c3
Set id: fe12519c-3e5f-4592-bd34-2d6b81b981f4
Version: 4
Effective Time: 20231122
 
TIME CAP LABS INC