Label: FIRST AID ONLY ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 0924-0204-01
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 47682-097
- 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 March 27, 2018
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- 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 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 •shock •asthma (wheezing)
If an allergic reaction occurs, stop use and seek medical help right away.
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 alcohol drinks every day while
using this product - take more or for a longer time than directed
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 prescription drugs for gout, diabetes or arthritis
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 lasts more than 3 days
- if ringing in the ears or loss of hearing occurs
- redness or swelling is present in the painful area
- any new symptoms appear
- an allergic reaction occurs. Seek medical help right away.
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Directions
- do not take more than directed
- the smallest effective dose should be used
- do not take longer than 10 days, unless
directed by a doctor (see Warnings) - drink a full glass of water with each dose
- Other information
- Inactive ingredients
- Questions or comments?
- First Aid Only Aspirin Label
-
INGREDIENTS AND APPEARANCE
FIRST AID ONLY ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-0204(NDC:47682-097) 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 CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) HYPROMELLOSES (UNII: 3NXW29V3WO) MINERAL OIL (UNII: T5L8T28FGP) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white (white) Score no score Shape ROUND (ROUND) Size 10mm Flavor Imprint Code TCL;011 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-0204-01 20 in 1 BOX, UNIT-DOSE 03/27/2018 1 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 final part343 12/30/2008 Labeler - Acme United Corporation (001180207) Registrant - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-0204) , repack(0924-0204) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-0204) , repack(0924-0204)
