ASPIRIN 5 GRAIN- aspirin tablet 
Provision Medical Products

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.

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Uses:

temporarily relieves pains due to:•headache • minor pain of arthritis•muscular aches • temporarily reduces fever•common cold

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

SPECIFICALLY 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. In

case of overdose, get medical help or

contact a Poison Control Center right

away. Prompt medical attention is

critical for adults as well as for children

even if you do not notice any signs or

symptoms.

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

Directions:

Adults and children 12 years of age and older take 2 tablets every 4 to 6hours as

needed, do not exceed 12 tablets in 24 hours, or as directed by

a doctor.

Children under 12 years consult a

doctor.

Do not use more than directed

Inactive Ingredients:

corn starch, povidone, silicon dioxide

and stearic acid.

ACTIVE INGREDIENT-ASPIRIN 325 MG

PAIN RELIEVER/FEVER REDUCER

5 GRAIN ASPIRIN BOX5 GRAIN ASPIRIN BOX

ASPIRIN 5 GRAIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2501
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
POVIDONE K30 (UNII: U725QWY32X)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize10mm
FlavorImprint Code FR21
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2501-5250 in 1 CARTON04/03/2015
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69103-2501-6100 in 1 CARTON04/03/2015
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34303/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(69103-2501)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2501)

Revised: 10/2019
Document Id: d267d8f5-1f6a-4bf2-92d7-256215e048f3
Set id: 052c35dc-e8b4-49e5-b626-2abba46e8dc8
Version: 2
Effective Time: 20191001
 
Provision Medical Products