Label: SOLVES - ASPIRIN CHERRY- aspirin strip
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Contains inactivated NDC Code(s)
NDC Code(s): 62309-779-01, 62309-779-02 - Packager: Pace Wellness Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated January 29, 2015
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each strip)
- Purposes
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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 early sign of Reye's Syndrome, a rare but serious illness.
Allergy alert
Aspirin may cause a severe allergic reaction, which may include: hives, facial swelling, asthma (wheezing), and shock.
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, 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 or take more or for a longer time than directed.
Ask a doctor before use if stomach bleeding warning applies to you, you have a history of stomach problems, such as heartburn, you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease, you are taking a diuretic, you have asthma or had a tonsillectomy or oral surgery in the last 7 days.
Ask a doctor or pharmacist before use if you are taking a prescription drug for gout, diabetes, arthritis or anticoagulation.
Stop and ask a doctor if an allergic reaction occurs (seek medical help right away), if you experience any of the following signs of stomach bleeding (feel faint, vomit blood, have bloody or black stools, stomach pain that does not get better), pain gets worse or lasts more than 10 days, fever lasts more than 3 days, redness or swelling is present, new symptoms occur, ringing in the ears or loss of hearing occurs.
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- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 5 Strip Pouch
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INGREDIENTS AND APPEARANCE
SOLVES - ASPIRIN CHERRY
aspirin stripProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62309-779 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Aspirin (UNII: R16CO5Y76E) (Aspirin - UNII:R16CO5Y76E) Aspirin 81 mg Inactive Ingredients Ingredient Name Strength Pectin (UNII: 89NA02M4RX) Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Sucralose (UNII: 96K6UQ3ZD4) Polysorbate 20 (UNII: 7T1F30V5YH) Lecithin, Soybean (UNII: 1DI56QDM62) Cellulose, Microcrystalline (UNII: OP1R32D61U) Cocoa Butter (UNII: 512OYT1CRR) Acesulfame Potassium (UNII: 23OV73Q5G9) Product Characteristics Color RED Score Shape RECTANGLE Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62309-779-01 5 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:62309-779-02 144 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part343 05/01/2014 Labeler - Pace Wellness Inc. (079275105) Establishment Name Address ID/FEI Business Operations Cure Pharmaceutical Inc. 019599644 MANUFACTURE(62309-779)
