Label: ADVANCED ASPIRIN- aspirin tablet
-
Contains inactivated NDC Code(s)
NDC Code(s): 67060-232-02, 67060-232-68 - Packager: ADVANCED FIRST AID, 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 April 7, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Uses:
temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis
•
muscle pain • pain and fever of colds • toothache • temporarily reduces fever
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 nonsteroidal anti-inflammatory drugs (NSAIDs),
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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or
others]
• 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
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 a sodium-restricted diet
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:
• you feel faint, vomit blood, or have bloody
or black stools
• redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts
more than 3 days
• new symptoms occur • ringing in the ears or a loss of hearing occurs
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ADVANCED ASPIRIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-232 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 Inactive Ingredients Ingredient Name Strength CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) Product Characteristics Color white (SNOW WHITE) Score no score Shape ROUND Size 10mm Flavor Imprint Code FR21 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-232-68 100 in 1 CARTON 04/07/2015 1 NDC:67060-232-02 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/07/2015 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-232) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-232)