Label: ASPIRIN 81MG tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70692-126-01 - Packager: Strive Pharmaceuticals Inc.
- 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.
Drug Label Information
Updated November 16, 2020
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
anhydrous lactose*, carnuba wax*, croscarmellose sodium, D&C yellow #10 aluminum lake, D&C yellow #6*, hydroxy propyl methyl cellulose, iron oxide*, isopropyl alcohol, magnesium stearate*, methacrylic acid copolymer type c, microcrystalline cellulose, polythylene glycol, polysorbate 80*, pregelatinized starch, silicon dioxide, sodium hydroxide*, sodium lauryl sulfate, stearic acid*, talc, titanium dioxide, triethyl citrate. *may contain.
- DOSAGE & ADMINISTRATION
- 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 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)
- 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 everyday while using this product
- Take more or for a longer time than directed.
Do not use
- If you are allergic to aspirin or any other pain reliever/fever reducer.\
- If you have ever had an allergic reaction to this product or any of its ingredients.
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
- You have asthma
Ask a doctor or pharmacist before use if you are taking a prescription drug for
- Gout
- Diabetes
- Arthritis
Stop use and ask a doctor if
- An allergic reaction occurs. Seek medical help right away.
- 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 last more than 10 days
- Redness or swelling is present
- Fever gets worse or last more than 3 days
- New symptoms occur
- Ringing in the ears or loss of hearing occurs
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.
OVERDOSE WARNING: In case of overdose, get medical help or contact a Poison Control right away. Prompt medical attention is critical for adults as well as children eve if you do not notice any signs or symptoms.
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 81MG
aspirin 81mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70692-126 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 ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK) HYPROMELLOSES (UNII: 3NXW29V3WO) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) SODIUM LAURYL SULFATE (UNII: 368GB5141J) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYSORBATE 80 (UNII: 6OZP39ZG8H) STARCH, CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) ISOPROPYL ALCOHOL (UNII: ND2M416302) FERRIC OXIDE RED (UNII: 1K09F3G675) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color yellow Score no score Shape ROUND Size 7mm Flavor Imprint Code A1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70692-126-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 02/15/2018 Labeler - Strive Pharmaceuticals Inc. (080028013)