FDA Label for Winco Foods Effervescent Antacid And Pain Relief

View Indications, Usage & Precautions

Winco Foods Effervescent Antacid And Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Winco Foods, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



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


Warnings



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 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.


Indications & Usage



Uses

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)


Otc - Ask Doctor



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


Otc - Ask Doctor/Pharmacist



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


Otc - Do Not Use



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.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


Otc - Pregnancy 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 definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.


Otc - Stop Use



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


Otc - When Using



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.


Otc - Purpose



Fast Relief of: Indigestion, Upset stomach, Heartburn with headache, Body Aches and Pains.


Dosage & Administration



Directions

- 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 years and over - 2 tablets every 4 hours do not exceed 4 tablets in 24 hours 


Inactive Ingredient



There are no inactive ingredients.


* Please review the disclaimer below.