REGULAR STRENGTH ENTERIC COATED ASPIRIN  - aspirin tablet, coated 
Geri-Care Pharmaceutical Corp

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.

----------

Active ingredient (in each tablet)

Aspirin 325 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

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 if you are allergic to aspirin or any other pain reliever/fever reducer.

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

Inactive ingredients

cellulose, D and C yellow #10, FD and C yellow #6, hypromellose, iron oxide, PEG, polydextrose, polyvinyl acetate phthalate, propylene glycol, shellac wax, silica, simethicone, sodium alginate, sodium bicarbonate, starch, stearic acid, talc, titanium dioxide, triacetin, triethyl citrate. May also contain: acetylated monoglycerides, croscarmellose sodium, hypromellose phthalate, methacrylic acid, mineral oil, polysorbate 80, sodium lauryl sulfate.

package label

GERICARE
NDC 57896-921-01
Regular Strength
ENTERIC COATED  ASPIRIN
pain reliever (NSAID)
PACKAGE NOT CHILD RESISTANT
100 Tablets
325 mg each
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

rs enteric coated aspirin label

REGULAR STRENGTH ENTERIC COATED ASPIRIN  
aspirin tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:57896-921
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
Color orange Score no score
Shape ROUND Size 9mm
Flavor Imprint Code 44;227
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:57896-921-01 100 in 1 BOTTLE
2 NDC:57896-921-10 1000 in 1 BOTTLE
3 NDC:57896-921-25 250 in 1 BOTTLE
4 NDC:57896-921-50 500 in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 07/01/2000
Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
Name Address ID/FEI Business Operations
Geri-Care Pharmaceutical Corp 611196254 repack(57896-921)

Revised: 11/2012
Document Id: a66ee68f-1dc7-4ca9-84c8-52290bfed369
Set id: c321208c-f192-42c5-9454-e0df5d02d685
Version: 1
Effective Time: 20121122
 
Geri-Care Pharmaceutical Corp