Label: UNISHIELD ASPIRIN- aspirin tablet, coated
UNISHIELD ASPIRIN- aspirin tablet, film coated
- NDC Code(s): 49314-1163-3, 49314-1173-3
- Packager: Unishield
- 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 August 14, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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 alcohol drinks every day while using this product
■ take more or for a longer time than directed
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
-
STOP USE
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 lasts more than 10 days
■ fever lasts more than 3 days
■ if ringing in the ears or loss of hearing occurs
■ redness or swelling is present
■ new symptoms occur
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Unishield Aspirin Label
Unishield
Aspirin 325 mg
Pain Reliever/Fever Reducer (NSAID)
100 Tablets/2Tablets Per Packet
Pull To Open
This Package is for Households Without Young Children.
• Relieves headaches,muscule pain and minor arthritis pain
Compare active ingredient to:
Genuine Bayerl®
Registered Trademark of Bayer Corp.
Tamper Evident Unit Dose Packets
-
Unishield Aspirin Label
Aspirin 325 mg
Pain Reliever/Fever Reducer (NSAID)
100 Tablets/2Tablets Per Packet
Pull To Open
This Package is for Households Without Young Children.
• Relieves headaches,muscule pain and minor arthritis pain
Compare active ingredient to:
Genuine Bayerl®
Registered Trademark of Bayer Corp.
Tamper Evident Unit Dose Packets
-
INGREDIENTS AND APPEARANCE
UNISHIELD ASPIRIN
aspirin tablet, coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1173 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 POVIDONE (UNII: FZ989GH94E) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color 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:49314-1173-3 50 in 1 BOX 03/01/2021 04/01/2024 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 not final part343 03/01/2021 04/01/2024 UNISHIELD ASPIRIN
aspirin tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49314-1163 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STARCH, CORN (UNII: O8232NY3SJ) Product Characteristics Color white Score no score Shape ROUND Size 10mm Flavor Imprint Code 44;157;ASPIRIN Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49314-1163-3 50 in 1 BOX 03/01/2021 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 not final part343 03/01/2021 Labeler - Unishield (790677053) Registrant - Unifirst First Aid Corporation (832947092) Establishment Name Address ID/FEI Business Operations Prestige Packaging 080667761 pack(49314-1163, 49314-1173)