DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

Direct Safety Aspirin by

Drug Labeling and Warnings

Direct Safety Aspirin by is a Otc medication manufactured, distributed, or labeled by Conney Safety Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever/fever reducer

Uses

Temporarily relieves minor aches and pains associated with

• headache
• minor arthritis pain
• common cold
• menstrual cramps
• muscular aches
• backache
• toothache

Temporarily reduces fever.

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

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

Do not use

• if you have ever had an allergic reaction to any other pain reliever/ fever reducer
• if you are taking prescription drugs for gout, diabetes or arthritis

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

• under a doctor's care for any serious condition
• taking any other drug

When using this product

• take with food or milk if stomach upset occurs

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

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 definitely 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.

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

Adults and children:             Take 1 or 2 tablets with water every 4 hours as needed. Do not
(12 years and older)             take more than 12 tablets in 24 hours, or as directed by a doctor.

Children under 12 years:      Do not give to children under 12 years of age.

Other information

• read all product information before using
• store at room temperature 59º-86ºF (15º-30ºC)
• avoid excessive heat and humidity
• tamper evident sealed packets
• do not use any opened or torn packets

Inactive ingredients

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

Questions or comments?

1-800-356-9100

Direct Safety Aspirin Label

Direct Safety®

Aspirin

Pain Reliever

Aspirin 325 mg. (NSAID)

Aspirina 325 mg. (AINE)

Lightly Coated

Industrial Pack 500

(250 Packets of 2 Tablets)

INGREDIENTS AND APPEARANCE

DIRECT SAFETY ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61245-116
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: 61245-116-13	250 in 1 BOX	05/03/2013
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	05/03/2013

Labeler - Conney Safety Products, LLC (023316151)