ASPRIN- aspirin tablet, delayed release
PLD Acquisitions LLC DBA Avéma Pharma Solutions
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.
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Drug Facts
Uses
- temporarily relieves minor aches and pains
- other therapy as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches, fever, or other symptoms needing immediate relief.
Warnings
Reye’s syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
- hives
- facial swelling
- asthma (wheezing)
- shock
Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 any other pain reliever/fever reducer
- right before or after heart surgery
Ask a doctor before use if you have:
- problems or serious side effects from taking pain relievers or fever reducers
- stomach problems (such as heartburn, upset stomach, or stomach pain) that last or come back
- bleeding problems
- ulcers
- asthma
- high blood pressure
- heart or kidney disease
- liver cirrhosis
- taken a diuretic
- reached the age of 60 or older
Ask a doctor or pharmacist before use if you are taking a prescription drug for:
- anticoagulation (thinning of the blood)
- gout
- diabetes
- arthritis
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- pain gets worse or lasts for more than 10 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
- you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
Pregnant or breast-feeding
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 SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING THE DELIVERY.
Directions
- do not exceed recommended dosage
- drink a full glass of water with each dose
- adults and children 12 years of age and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours, unless directed by a doctor
- children under 12 years of age: consult a doctor
- do not use in children under 4 years of age
Other information
store at controlled room temperature 15°-30°C (59°-86°F)
do not use if imprinted safety seal under cap is broken or missing
**This product is not manufactured or distributed by Bayer Corporation Consumer Care Division, owner of the registered trademark Aspirin Regimen Bayer® 81 mg
Inactive ingredients
*acetylated monoglycerides, *anhydrous lactose, colloidal silicon dioxide, *corn starch, *croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, *hypromellose phthalate, *iron oxide Yellow (iron oxide ochre), methacrylic acid copolymer, microcrystalline cellulose, *mineral oil, *polyethylene glycol (PEG)-400, *polysorbate 80, pregelatinized starch, *propylene glycol, sodium bicarbonate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacitin, and triethyl citrate. *May also contain.
| ASPRIN
aspirin tablet, delayed release |
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| Labeler - PLD Acquisitions LLC DBA Avéma Pharma Solutions (804087794) |