Label: ASPIRIN 5 GRAIN- aspirin tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 69103-2501-5, 69103-2501-6 - Packager: Provision Medical Products
- 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 October 1, 2019
If you are a consumer or patient please visit this version.
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- INDICATIONS & USAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS
Warnings:
Reye's syndrome: Children and teenagers should not
use this medicine for chicken pox or -u symptoms
before a doctor is consulted about Reye's syndrome, a
rare but serious illness reported to be associated with
aspirin.
Alcohol Warning: If you consume 3 or more alcoholic
drinks every day, ask your doctor whether you should
take aspirin or other pain relievers/fever reducers.
Aspirin may cause stomach bleeding.
Do not use:
•
if you are allergic to aspirin
•
with any other pain reliever/fever reducer
•
if you have ever had an allergic reaction to any
other pain reliever/fever reducer
•
for pain for more than 10 days or for fever for
more than 3 days unless directed by a doctor
•
with any other product containing aspirin
Ask a doctor before using if you have:
•
asthma • gastric ulcers • bleeding problems
•
stomach problems (such as heartburn, upset stomach
or stomach pain)
Ask a doctor or pharmacist before use if you are
taking a prescription drug for:
• anticoagulation
(thinning of blood)
• diabetes • gout • arthritis
Stop use and ask a doctor if:
•
ringing in the ears or loss of hearing occurs
•
pain or fever persists or gets worse
•
new symptoms occur
•
redness or swelling is present
When using this product do not exceed
recommended dose
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ASPIRIN 5 GRAIN
aspirin tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2501 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 K30 (UNII: U725QWY32X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 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:69103-2501-5 250 in 1 CARTON 04/03/2015 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69103-2501-6 100 in 1 CARTON 04/03/2015 2 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 03/31/2015 Labeler - Provision Medical Products (036936831) Registrant - Provision Medical Products (036936831) Establishment Name Address ID/FEI Business Operations Ultraseal Corporation 085752004 pack(69103-2501) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(69103-2501)
