Label: PLUS PHARMA NSAID 325 MG- aspirin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 64725-0716-1 - Packager: TYA Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 51645-716
- 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.
Drug Label Information
Updated September 29, 2014
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purposes
- Uses
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Warnings
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. Reye's syndrome:
Aspirin may cause a severe allergic reaction, which may include Allergy alert:
- hives
- facial swelling
- asthma(wheezing)
- shock
This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you Stomach bleeding warning:
- 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
with any other product containing Aspirin or if you have ever had an allergic reaction to aspirin or other pain relievers/fever reducers.
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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- anticoagulation (blood thinning)
- gout
- diabetes
- arthritis
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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms occur
- ringing in the ears or hearing loss occurs
- redness or swelling is present
- hives
- Directions
- Other information
- Inactive ingredients
- Questions?
- PLUS PHARMA NSAID 325 MG (ASPIRIN) TABLET
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INGREDIENTS AND APPEARANCE
PLUS PHARMA NSAID 325 MG
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64725-0716(NDC:51645-716) 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 STARCH, CORN (UNII: O8232NY3SJ) POVIDONES (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape ROUND (bi-convex tablet) Size 10mm Flavor Imprint Code Aspirin;GPI Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64725-0716-1 100 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 09/29/2014 Labeler - TYA Pharmaceuticals (938389038) Registrant - TYA Pharmaceuticals (938389038) Establishment Name Address ID/FEI Business Operations TYA Pharmaceuticals 938389038 RELABEL(64725-0716) , REPACK(64725-0716)
