Label: EXTRA STRENGTH ASPIRIN tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69517-115-60 - Packager: Healthlife of USA
- 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 October 10, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug facts
- Purpose
- Active ingredient (in each tablet)
- Uses
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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 behaviour 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 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
- Do not use
- Ask a doctor before use if
- Ask a doctor or pharmacist before use if you are
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Stop use and ask a doctor if:
- you experience any of the following signs of stomach bleeding:
- feel faint
- have bloody or black stools
- vomit blood
- have stomach pain that does not get better
2. an allergic reaction occurs.
- seek medical help right away.
3. ringing in the ears or loss of hearing occurs
4. pain gets worse or lasts for more than 3 days
5. redness or swelling present
6. new symptoms occur
These could be sign of a serious condition.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- Do not take more than directed
- Drink a full glass of water with each dose
- Adults and children 12 years of age and over:
- take 1 to 2 tablets every 4 hours while symptoms last
- do not take more than 12 tablets in 24 hours unless directed by a doctor
- do not use for more than 10 days unless directed by a doctor
- Children under 12 years: do not use unless directed by a doctor
- Other Information
- Inactive ingredients
- Questions or comments?
- Extra Strength Aspirin Aspirin 325 mg 60 Tablets Compare to Bayer® EXTRA STRENGTH active ingredients
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INGREDIENTS AND APPEARANCE
EXTRA STRENGTH ASPIRIN
extra strength aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69517-115 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 CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) MINERAL OIL (UNII: T5L8T28FGP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69517-115-60 1 in 1 CARTON 05/31/2017 1 60 in 1 BOTTLE; 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 05/31/2017 Labeler - Healthlife of USA (079656178) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc. 037052099 manufacture(69517-115) , pack(69517-115)
