Label: EFFERVESCENT ANTACID AND PAIN RELIEF- aspirin, sodium bicarbonate, citric acid tablet, effervescent
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated September 14, 2012
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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 should not use this drug 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 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.
Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take aspirin or other pain relievers/fever reducers. Aspirin may cause stomach bleeding.
- INDICATIONS & USAGE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
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
DOSAGE & ADMINISTRATION
- 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
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EFFERVESCENT ANTACID AND PAIN RELIEF
aspirin, sodium bicarbonate, citric acid tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-196 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) BICARBONATE ION 1916 mg ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS CITRIC ACID 1000 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor Imprint Code L421 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-196-68 36 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 12/01/2006 Labeler - Cardinal Health Inc. (097537435) Registrant - United Exchange Corporation (840130579) Establishment Name Address ID/FEI Business Operations Tower Laboratories Ltd 869024500 manufacture(37205-196)