Label: ASPIRIN 325 MG EC- aspirin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70934-561-90 - Packager: Denton Pharma, Inc. dba Northwind Pharmaceuticals
- This is a repackaged label.
- Source NDC Code(s): 69618-015
- 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 May 5, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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 prodcut, 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.
- OTHER SAFETY INFORMATION
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OTHER SAFETY INFORMATION
Stomach bleeding warning: This prodcut 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 (ibuprofen, naproxen, or others)
- take more or for a longer time than directed
- have 3 or more alcoholic drinks every day while using this product
Drug Facts continued on back of label
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
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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
- pain gets worse or lasts more than 10 days
- fever gets worse or lasta more than 3 days
- redness or swelling is present in the painful area
- any new symptoms appear
- ringing in the ears or loss of hearing occurs
These could be sings of a serious condition
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
ASPIRIN 325 MG EC
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70934-561(NDC:69618-015) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength POVIDONE (UNII: FZ989GH94E) METHACRYLIC ACID (UNII: 1CS02G8656) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, CORN (UNII: O8232NY3SJ) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) HYPROMELLOSES (UNII: 3NXW29V3WO) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TALC (UNII: 7SEV7J4R1U) SODIUM LAURYL SULFATE (UNII: 368GB5141J) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) Product Characteristics Color orange Score no score Shape ROUND Size 10mm Flavor Imprint Code AP;110 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70934-561-90 90 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/05/2020 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part343 05/05/2020 Labeler - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546) Registrant - Denton Pharma, Inc. dba Northwind Pharmaceuticals (080355546) Establishment Name Address ID/FEI Business Operations Denton Pharma, Inc. dba Northwind Pharmaceuticals 080355546 repack(70934-561)
