OTC Medication Information: ADULT LOW DOSE ASPIRIN

ADULT LOW DOSE ASPIRIN- aspirin tablet, delayed release
ASPIRIN- aspirin tablet
DIRECT RX

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.

Aspirin 81mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Pain Reliever

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product may not provide fast relief of headache or other symptoms needing immediate relief.
ask your doctor about other uses for this product

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
asthma (wheezing)
facial swelling
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 you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

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

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

gout
diabetes
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
allergic reaction occurs
pain gets worse or lasts more than 10 days
redness or swelling is present
any new symptoms occur
ringing in the ears or loss of hearing occurs

These could be signs of a serious condition.

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 accidental overdose, get medical help or contact a Poison Control Center right away.

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours while symptoms persist. Do not to exceed 48 tablets in 24 hours or as directed by a physician
children under 12 years: consult a physician

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature (15°-30°C) avoid excess heat and moisture

croscarmellose sodium, D&C yellow# 10 lake, FD&C yellow #6, hypromellose, methacrylic acid copolymer, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide.

(866) 562-2756

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ADULT LOW DOSE ASPIRIN aspirin tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-188(NDC:16103-356)
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
FD&C YELLOW NO. 6
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 600000 MW)
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL, UNSPECIFIED
STARCH, CORN
SODIUM LAURYL SULFATE
STEARIC ACID
TALC
TITANIUM DIOXIDE
CROSCARMELLOSE SODIUM
D&C YELLOW NO. 10
HYPROMELLOSES
Product Characteristics
Color yellow Score no score
Shape ROUND Size 8mm
Flavor Imprint Code PH023
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-188-60 60 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 06/04/2021
ASPIRIN aspirin tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:72189-187(NDC:57896-901)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 325 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 44;249;ASPIRIN
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72189-187-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 06/04/2021
Labeler — DIRECT RX (079254320)
Registrant — DIRECT RX (079254320)
Establishment
Name Address ID/FEI Operations
DIRECT RX 079254320 repack (72189-188), repack (72189-187)

Revised: 06/2021 DIRECT RX

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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