CRANE SAFETY ASPIRIN- aspirin tablet, film coated

Crane Safety Aspirin by

Drug Labeling and Warnings

Crane Safety Aspirin by is a Otc medication manufactured, distributed, or labeled by Crane Safety, LLC., Unifirst First Aid Corporation, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

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
• 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 aspirin or any other pain reliever/ fever reducer
• if you ever had an allergic reactioin to this product or any of its ingredients

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

taking a prescription drug for

• gout
• diabetes
• arthritis

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

• drink a full glass of water with each dose

Adults and children: (12 years and older)

Take 1 or 2 tablets with water every 4 hours or 3 tablest every 6 hours, not to exceed 12 tablets in 24 hours.

Children under 12 years:

Do not give to children under 12 years of age unless directed by a doctor..

Other information

• use by expiration date on package
• store at 77ºF (25ºC); excursions permitted between 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*, polyethylene glycol*, propylene glycol*, titanium dioxide*

may contain*

Questions or comments?

877.506.4291

Crane Safety Aspirin Label

5 Grain (325 mg)

ASPIRIN

PainReliever/Fever Reducer (NSAID)

CRANE Safety®

Pull To Open

This Package Is For Households Without Young Children.

Aches, Fever

Aspirin (NSAID) 325 mg

100 Tablets

Tamper Evident

Sealed Packets

INGREDIENTS AND APPEARANCE

CRANE SAFETY ASPIRIN 
aspirin tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-099(NDC: 47682-099)
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)
MINERAL OIL (UNII: T5L8T28FGP)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-099-33	50 in 1 BOX	01/17/2020
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	01/17/2020

Labeler - Crane Safety, LLC. (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(73408-099)

Establishment
Name	Address	ID/FEI	Business Operations
Prestige Packaging		170837962	relabel(73408-099) , repack(73408-099)