ASPIRIN- aspirin tablet 
Apotheca, 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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ASPIRIN TABLETS USP, 325 MG

ACTIVE INGREDIENT

Each tablet contains Aspirin 325 mg
Aspirin (Acetysalicylic Acid) 325 mg (5gr.) (NSAID)*

PURPOSE

Pain Reliever

Uses:

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.

KEEP OUT OF REACH OF CHILDREN

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

USES

Provides temporary relief of

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, asthma (wheezing)

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.

DOSAGE & ADMINISTRATION

Drink a full glass of water with each dose

Adults and children 12 years and over: take 1 to 2 tablets every 4 hours while symptoms last

Do not take more than 12 tablets in 24 hours unless directed by a doctor.

Children under 12 years: consult a doctor

corn starch, croscarmellose sodium, Hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

PRINCIPAL DISPLAY PANEL

MANUFACTURED BY:

Time-Cap Labs, Inc

Farmingdale, NY 11735

Repackaged & Relabeled by:

Apotheca, Inc

Phoenix, AZ 85006

Repackaged & Relabeled for:

RejuviLife

Phoenix, AZ 85006

NDC 12634-120-74

ASPIRIN

ANALGESIC

PAIN RELIEVER

REJUVILIFE

24 TABLETS

325 MG (5 GR EACH)

ASPIRIN

ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12634-120(NDC:49483-011)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 g
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
MINERAL OIL (UNII: T5L8T28FGP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUND (MICRO COATED CLEAR) Size10mm
FlavorImprint Code TCL;011
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12634-120-7424 in 1 BOTTLE
2NDC:12634-120-6060 in 1 BOTTLE
3NDC:12634-120-01100 in 1 BOTTLE
4NDC:12634-120-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/15/1983
Labeler - Apotheca, Inc (051457844)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca, Inc051457844repack(12634-120)

Revised: 10/2013
Document Id: 9e5f53d8-1f64-4021-8b6e-7f74694919ab
Set id: 01cdc525-f51f-4779-9e3b-01a35dd3bcac
Version: 2
Effective Time: 20131011
 
Apotheca, Inc