ASPIRIN 5 GRAIN- aspirin tablet

Aspirin 5 grain by

Drug Labeling and Warnings

Aspirin 5 grain by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, Ultraseal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Uses:

temporarily relieves pains due to:headache minor pain of arthritismuscular aches temporarily reduces fevercommon cold

PREGNANCY OR BREAST FEEDING

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

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

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

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 INGREDIENT

Inactive Ingredients:

corn starch, povidone, silicon dioxide

and stearic acid.

ACTIVE INGREDIENT

ACTIVE INGREDIENT-ASPIRIN 325 MG

PURPOSE

PAIN RELIEVER/FEVER REDUCER

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ASPIRIN 5 GRAIN 
aspirin tablet

Product 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)