Label: ASPIRIN - aspirin tablet
- NDC Code(s): 76168-009-10
- Packager: Velocity Pharma
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 October 23, 2013
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- Active Ingredient
(in each tablet)
Aspirin 81 mg (NSAID)Close
- temporarily relieves minor aches and pains
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:
- Asthma (wheezing)
- Facial Swelling
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 other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)
- have 3 or more alcoholic drinks every day while using this product
- takes more or for a longer time than directed
Do not use
- if you have ever had an allergic reaction to any pain reliever or fever reducer.
Ask a doctor before use if:
- The stomach bleeding warning applies to you
- You have history of stomach problems such as heartburn
- You have high blood pressure, heart disease, liver cirrhosis, or kidney disease
- You have asthma
- You are taking a diuretic
Ask a doctor or pharmacist before use if you are taking a prescription drug for :
Stop use and ask a doctor if
- you experiences any of the following signs of stomach bleeding:
- feels faint
- vomits blood
- has bloody or black stools
- has stomach pain that does not get better
- pain gets worse or lasts more than 10 days
- New symptoms occur
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
These could be signs of serious conditions.
If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.Close
Adults and Children 12 years and over:
For temporary relief of minor aches and pains, take 4 to 8 tablets every 4 hours while symptoms persist. Do not exceed 48 tablets in 24 hours unless directed by a doctor.
Children under 12 years of age: Do not use unless directed by a doctor.Close
- Other Information
- Store at a controlled temperature between 62 and 77 degrees F
- Inactive Ingredients
Anhydrous Lactose, Carnuba Wax Colloidal Sillicon Dioxide, Crosscarmellose Sodium,FD&C Yellow #10 al lake, FD&C Yellow#6 al Lake, Iron Oxide Ochre, Methacrylic acid copolymer, Micro crystalline cellulose, Polysorbate 80, simethiocone, sodium hydroxide, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate.Close
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Velocity Pharma LLCClose
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC: 76168-009-10 –60 COUNT
Enteric Coated to help prevent upset stomachClose
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76168-009 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 CARNAUBA WAX (UNII: R12CBM0EIZ) ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) BROWN IRON OXIDE (UNII: 1N032N7MFO) METHACRYLIC ACID (UNII: 1CS02G8656) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DIMETHICONE (UNII: 92RU3N3Y1O) SODIUM HYDROXIDE (UNII: 55X04QC32I) SODIUM LAURYL SULFATE (UNII: 368GB5141J) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) Product Characteristics Color YELLOW Score no score Shape ROUND Size 7mm Flavor Imprint Code A Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76168-009-10 60 in 1 BOTTLE 1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/2011 Labeler - Velocity Pharma (962198409) Registrant - Velocity Pharma (962198409)