DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)
Available from:
Conney Safety Products, LLC
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Pain reliever/fever reducer Temporarily relieves minor aches and pains associated with - headache - minor arthritis pain - common cold - menstrual cramps - muscular aches - backache - toothache Temporarily reduces fever.
Authorization status:
OTC monograph final
Authorization number:
61245-116-13

DIRECT SAFETY ASPIRIN- aspirin tablet, film coated

Conney Safety Products, LLC

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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Direct Safety Aspirin

Drug Facts

Active ingredient (in each tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Purpos e

Pain reliever/fever reducer

Us es

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,

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)

DIRECT SAFETY ASPIRIN

aspirin tablet, film coated

Product Information

Conney Safety Products, LLC

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 1245-116

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

325 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

CRO SCARMELLO SE SO DIUM (UNII: M28 OL1HH48 )

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MINERAL O IL (UNII: T5L8 T28 FGP)

STARCH, CO RN (UNII: O8 232NY3SJ)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white (white)

S core

no sco re

S hap e

ROUND (ROUND)

S iz e

10 mm

Flavor

Imprint Code

TCL;0 11

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 1245-116 -13

250 in 1 BOX

0 5/0 3/20 13

0 8 /31/20 22

1

2 in 1 PACKET; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt343

0 5/0 3/20 13

0 8 /31/20 22

Labeler -

Conney Safety Products, LLC (023316151)

Revised: 7/2020

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