ASPIRIN- aspirin tablet
Aphena Pharma Solutions — Tennessee, LLC
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.
(in each tablet)
Aspirin 325 mg (NSAID) *
*nonsteroidal anti-inflammatory drug
Pain reliever/ Fever Reducer
- menstrual pain
- muscle pain
- minor pain or arthritis
- pain and fever of colds
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 signs of Reye’s syndrome, a rare but serious illness.
Allergy Alert: Aspirin may cause a severe allergic reaction which may include
- asthma (wheezing)
- facial swelling
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
- takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others)
- takes more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product.
Do not use
- if you have ever had an allergic reaction to any other pain reliever / fever reducer
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have a history of stomach problems, such as heartburn
- you have high blood pressure, heart disease, lever cirrhosis, or kidney disease
- you are taking a diuretic
- you have asthma
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout or arthritis
- taking any other drug
- under a doctor’s care for any serious condition
Stop use and ask a doctor if
- you experiences 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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or a 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.
In case of 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 : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours.
- Children under 12 years: ask a doctor
- avoid excessive heat or humidity
- store at 15-30 °C (59-86 °F)
croscarmellose sodium, D&C Yellow #10 (Al-Lake), FD&C yellow #6 (Al-Lake), HPMC, methacrylic acid copolymer, polyethylene glycol, propylene glycol, PVP, sodium lauryl sulfate, starch, stearic acid, talc, titanium dioxide
Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742
Please reference the How Supplied section listed above for a description of individual tablets. This drug product has been received by Aphena Pharma — TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:
Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.
Cookeville, TN 38506
NDC 71610-034 — Aspirin EC (NSAID) 325mg — Rx Only
| ASPIRIN |
|Labeler — Aphena Pharma Solutions — Tennessee, LLC (128385585)|
|Aphena Pharma Solutions — Tennessee, LLC||128385585||REPACK (71610-034)|
Revised: 02/2018 Aphena Pharma Solutions — Tennessee, LLC
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.