OTC Medication Information: Adult Low Dose Enteric Coated Aspirin

ADULT LOW DOSE ENTERIC COATED ASPIRIN- aspirin tablet, delayed release
Preferred Pharmaceuticals 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.

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 controlled room temperature

Inactive ingredients

anhydrous lactose, black iron oxide, brown iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C yellow #10 aluminum
lake, hypromellose, iron oxide ochre, methacrylic acid copolymer, microcrystalline cellulose, mineral oil, polysorbate 80, potassium hydroxide, propylene glycol, shellac, simethicone, sodium hydroxide, sodium lauryl sulfate, starch, talc, titanium dioxide, triethyl citrate

package label

GERICARE

Repackaged By: Preferred Pharmaceuticals Inc.
NDC 68788-7107
ADULT LOW DOSE
ENTERIC COATED

ASPIRIN
pain reliever (NSAID)
81 mg each
Compare to the active ingredient in Bayer low dose aspirin*

Asprin Tablets Enteric Coated 325mg
(click image for full-size original)
ADULT LOW DOSE ENTERIC COATED ASPIRIN
aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7107(NDC:57896-985)
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
ANHYDROUS LACTOSE
CROSCARMELLOSE SODIUM
POLYSORBATE 80
POTASSIUM HYDROXIDE
SODIUM HYDROXIDE
MINERAL OIL
FERROSOFERRIC OXIDE
STARCH, CORN
D&C YELLOW NO. 10
HYPROMELLOSE, UNSPECIFIED
METHACRYLIC ACID — ETHYL ACRYLATE COPOLYMER (1:1) TYPE A
MICROCRYSTALLINE CELLULOSE
PROPYLENE GLYCOL
SHELLAC
DIMETHICONE
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
BROWN IRON OXIDE
SILICON DIOXIDE
Product Characteristics
Color yellow Score no score
Shape ROUND Size 7mm
Flavor Imprint Code T81
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7107-1 100 TABLET, DELAYED RELEASE in 1 BOTTLE None
2 NDC:68788-7107-8 120 TABLET, DELAYED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 03/08/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7107)

Revised: 03/2020 Preferred Pharmaceuticals Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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