First Aid Direct Aspirin by Cintas Corporation First Aid Direct Aspirin

First Aid Direct Aspirin by

Drug Labeling and Warnings

First Aid Direct Aspirin by is a Otc medication manufactured, distributed, or labeled by Cintas Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FIRST AID DIRECT ASPIRIN- aspirin tablet 
Cintas Corporation

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.

----------

First Aid Direct Aspirin

Purpose

Active ingredient (in each tablet)
Aspirin 325mg (Nonsteroidal Anti-Inflammatory Drug (NSAID)…….Pain reliever/Fever reducer

Uses

Temporarily relieves fever and minor aches and pains associated with:
Headache
Colds
Muscular aches
Menstrual discomfort
Toothache
Minor arthritis pain

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
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 alcoholic drinks every day while using this product
Take more or for a longer time than directed
Do not use
If you are allergic to aspirin
With 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
Ask a doctor before use if:
The stomach bleeding warning applies to you
You have liver disease, high blood pressure, heart disease, liver cirrhosis, asthma, or kidney disease
You are taking a diuretic
You have a history of stomach problems such as heartburn
Ask a doctor or pharmacist before use if are taking a prescription drug for:
Anticoagulation (thinning of blood)
Diabetes
Gout
Arthritis
When using this product do not exceed recommended dose
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
Ringing in the ears or loss of hearing occurs
Pain or fever persists or gets worse
New symptoms occur
Redness or swelling is present
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 pregnancy.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed, do not exceed 12 tablets in 24 hours, or as directed by a doctor.
Children under 12 years of age: Ask a doctor.

Other Information

Do not use if packet is torn, cut, or opened
Store at room temperature
Avoid excessive heat and humidity
Questions? 1-800-327-2704 M – F 8AM – 5PM (CDT)
2 tablets per packet

Active Ingredient

Aspirin............... 325mg

Inactive Ingredients

Corn Starch, microcrystalline cellulose, povidone, silicon dioxide, and stearic acid

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 attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Principal Display Panel - Wrapper

ORIGINAL STRENGTH

ASPIRIN

wrapper-01

Principal Display Panel - 50 count Box

ORIGINAL STRENGTH

ASPIRIN

50 Tablets

2 Tablets per packet

box-50

Principal Display Panel - 100 count Box

ORIGINAL STRENGTH ASPIRIN

100 Tablets  2 Tablets per packet

box-100

FIRST AID DIRECT ASPIRIN 
aspirin tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 42961-113
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE (UNII: FZ989GH94E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize7mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 42961-113-0250 in 1 BOX04/19/2021
1NDC: 42961-113-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
2NDC: 42961-113-03100 in 1 BOX04/19/2021
2NDC: 42961-113-012 in 1 PACKET; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34304/19/202112/30/2022
Labeler - Cintas Corporation (056481716)
Registrant - Cintas Corporation (056481716)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(42961-113)

Revised: 12/2022
 

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.