DrugCite

ADULT LOW DOSE ENTERIC COATED ASPIRIN  - aspirin tablet, coated 
Geri-Care Pharmaceutical Corp

Active ingredient (in each tablet)

Aspirin 81 mg(NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

  • for the temporary relief of minor aches and pains
  • ask your doctor about other uses for aspirin

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
  • asthma (wheezing)
  • shock
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

Do not use if your are allergic to aspirin or any other pain reliever/fever reducer.

Ask a doctor before use if

  • the stomach bleeding warning applies to you
  • you are taking a diuretic
  • you have a history of stomach problems, such as heartburn
  • you have: -high blood pressure -heart disease -liver cirrhosis  -kidney disease -asthma

Ask a doctor or pharmacist before use if you are

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding: -feel faint -vomit blood -have bloody or black stools -have stomach pain that does not get better
  • an allergic reaction occurs. Seek medical help right away
  • pain gets worse or lasts more than 10 days
  • redness or swelling is present
  • fever gets worse or lasts more than 3 days
  • any new symptoms occur
  • ringing in the ears or 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 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

  • drink a full glass of water with each dose
  • swallow whole, do not chew or crush
  • do not exceed recommended dose
  • adults and children 12 years and older: take 4-8 tablets every 4 hours, as needed, not more than 48 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

  • store at room temperature 15⁰C - 30⁰C (59⁰F - 86⁰F)
  • for institutional use only

Inactive ingredients

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

package label

GERICARE
NDC 57896-981-01
SEE NEW WARNINGS
ADULT LOW DOSE
ENTERIC COATED  ASPIRIN
pain reliever (NSAID)
orange flavored
PACKAGE NOT CHILD RESISTANT
100 Tablets
81 mg each
Compare to the active ingredient in Bayer low dose aspirin*
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.

low dose aspirin label


ADULT LOW DOSE ENTERIC COATED ASPIRIN 
aspirin  tablet, coated
Product Information
Product Type HUMAN OTC DRUG NDC Product Code (Source) 57896-981 (50844-600)
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 81 mg
Inactive Ingredients
Ingredient Name Strength
FERROSOFERRIC OXIDE  
STARCH, CORN  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
HYPROMELLOSES  
METHACRYLIC ACID  
CELLULOSE, MICROCRYSTALLINE  
POLYDEXTROSE  
POLYETHYLENE GLYCOLS  
PROPYLENE GLYCOL  
SHELLAC  
SILICON DIOXIDE  
DIMETHICONE  
SODIUM BICARBONATE  
SODIUM LAURYL SULFATE  
TALC  
TITANIUM DIOXIDE  
TRIACETIN  
TRIETHYL CITRATE  
Product Characteristics
Color yellow Score no score
Shape ROUND Size 6mm
Flavor Imprint Code L
Contains     
Packaging
# NDC Package Description Multilevel Packaging
1 57896-981-01 100 TABLET In 1 BOTTLE None
2 57896-981-10 1000 TABLET In 1 BOTTLE None
3 57896-981-30 300 TABLET In 1 BOTTLE None
4 57896-981-12 120 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 07/01/2023

Labeler - Geri-Care Pharmaceutical Corp (611196254)
Registrant - Geri-Care Pharmaceutical Corp (611196254)
Establishment
Name Address ID/FEI Operations
Geri-Care Pharmaceutical Corp 611196254 repack
Revised: 08/2012Geri-Care Pharmaceutical Corp