Rapid Comfort Aspirin

Dosage form: tablet, film coated
Ingredients: ASPIRIN 325mg
Labeler: Lab Safety Supply, Inc.
NDC Code: 60683-106

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.

RAPID Comfort™

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
  • skin reddening
  • facial swelling
  • rash
  • asthma (wheezing)
  • blisters
  • 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
  • right before or after heart surgery
  • 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
  • you have difficulty swallowing
  • 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: (12 years and older) Take 1 or 2 tablets with water every 4 hours as needed. Do not 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? 1-800-356-0783

116R LSS -Aspirin 325 mg Label

Rapid Comfort TM

ASPIRIN

5 grain (325 mg) (NSAID)

Easy to Swallow

Film-Coated Tablets

Pull to Open

Compare active ingredients to:

Bayer®

Registered Trademark of Bayer Consumer

100 Tablets (50x2s)

Tamer-Evident Unit Dose Packets

RAPID COMFORT ASPIRIN 
aspirin tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60683-106
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (ASPIRIN) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
CROSCARMELLOSE SODIUM 
HYPROMELLOSES 
MINERAL OIL 
STARCH, CORN 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint CodeTCL;011
Contains    
Packaging
#Item CodePackage Description
1NDC:60683-106-13250 PACKET (250 PACKET) in 1 BOX, UNIT-DOSE
12 TABLET, FILM COATED (2 TABLET) in 1 PACKET
2NDC:60683-106-3350 PACKET (50 PACKET) in 1 BOX, UNIT-DOSE
22 TABLET, FILM COATED (2 TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34310/14/2011
Labeler - Lab Safety Supply, Inc. (042851410)
Establishment
NameAddressID/FEIOperations
Time Cap Labs, Inc.037052099MANUFACTURE

Revised: 10/2011
 
Lab Safety Supply, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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