(aspirin, sodium bicarbonate, citric acid)
[Tower Laboratories Ltd]
|Category||DEA Schedule||Marketing Status|
|HUMAN OTC DRUG LABEL||OTC monograph final|
Active Ingredients (in each effervescent tablet) Purpose
Aspirin 325mg NSAID* ............................................. Pain Reliever
Citric Acid 1000 mg ................................................... Antacid
Sodium Bicarbonate (heat-treated) 1916 mg ................ Antacid
*Nonsteroidal anti-inflammatory drug
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 ealy sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Aspirin may casue a sever 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 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.
for the temporary relief of
■ heartburn, acid indigestion and sour stomach when accompanied by headache or body aches and pains
■ upset stomach with headache from overindulgence in food or drink
■ pain alone (headaches or body aches and pains)
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, liver cirrhosis, or kidney disease - you are taking a diuretic - you have a sodium-restricted diet
Ask a doctor or pharmacist before use if you are - presently taking a prescription drug. Antacids may interact with certain prescription drugs. - taking a prescription drug for anticoagulation (thinning the blood), diabetes, gout or arthritis
Do not use - if you have ever had an allergic reaction to any other pain reliever/fever reducer - if you are allergic to aspirin - if overly full from food or drink. Ask a doctor if sever stomach pain occurs after taking this product.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
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.
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 lasts for more than 10 days or gets worse - new symptoms occur - redness or swelling is present - ringing in the ears or a loss of hearing occurs
When using this product do not take more than 8 tables (adults) and 4 tablets (60 years and over) in a 24-hour period or use the maximum dosage for more than 10 days.
- do not exceed recommended dosage
- to avoid serious injury, completely dissolve tablets in 4 oz. of water before taking
|adults and children 12 years and over|
(up to 60 years of age)
|2 tablets every 4 hours
do not esceed 8 tablets in 24 hours
|60 year and over||
2 tablets every 4 hours
do not exceed 4 tablets in 24 hours
aspirin, sodium bicarbonate, citric acid tablet, effervescent
|Labeler - Tower Laboratories Ltd (001587203)|
|Registrant - Tower Laboratories Ltd (869024500)|
|Tower Laboratories Ltd||869024500||manufacture(50201-0421)|