ASPIRIN EXTRA STRENGTH- aspirin tablet, 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.

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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

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 cause 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

Other information

corn starch, croscarmellose, hypromellose, microcrystalline cellulose,mineral oil, titanium dioxide

Use for the temporary relief of minor aches and pains due to:

headache, colds, muscle pain, menstrual pain, toothache, minor pain of arthritis or as directed by your doctor

Pain Reliever/fever reducer

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: hives, facial swelling, shock, asthmaaa9wheezing)

Stomach bleeding warning:  This product contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinning (anticoagulant) or steroid drug, take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed.

In each Tablet Asprin 500 mg (NSAID*) *non-steroidal anti-inflammatory drug

label copy

ASPIRIN  EXTRA STRENGTH
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-382
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg  in 500 
Inactive Ingredients
Ingredient Name Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color white Score no score
Shape ROUND Size 12mm
Flavor Imprint Code TCL382
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-382-01 100 in 1 BOTTLE, PLASTIC
2 NDC:49483-382-00 100000 in 1 CARTON
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 02/11/2013
Labeler - Time-Cap Labs, Inc (037052099)
Establishment
Name Address ID/FEI Business Operations
Time-Cap Labs, Inc 037052099 manufacture(49483-382)

Revised: 2/2013
Document Id: adca4a69-3258-4604-955e-a8e3d46d102b
Set id: efc7d42a-241a-422d-bc08-be2f5f774b62
Version: 1
Effective Time: 20130211
 
Time-Cap Labs, Inc