Otc - Active Ingredient
Active ingredient (in each tablet)
Aspirin325 mg (NSAID*)
*nonsteroidal anti-inflammatory drug
Aspirin Packs Tablet, Film Coated
FDA Label NDC 70385-2006
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sina Health Inc for the product Aspirin Packs (NDC 70385-2006). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Pain reliever/fever reducer
Indications & Usage
Uses
Temporarily relieves
- headache
- toothache
- pain and fever of colds
- muscle pain
- menstrual pain
- minor pain of arthritis
Warnings
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
- 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
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:
Otc - Do Not Use
Do not useif you are allergic to aspirin or to any other pain reliever/fever reducer
Otc - Ask Doctor
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
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you aretaking a prescription drug for
- gout
- diabetes
- arthritis
Otc - Stop Use
Stop use and ask a doctor if
- an allergic reaction occurs. Seek medical help right away.
- you experience any of the following signs of stomach bleeding:
- 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
- new symptoms appear
■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definately directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
Otc - 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.
Dosage & Administration
Directions
- drink a full glass of water with each dose
Adults and children:Take 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, not to exceed 12 tablets in 24 hours.
(12 years and over)
Children under 12 years:Consult a doctor
Other Safety Information
Other information
- store at room temperature
- avoid excessive heat and humidity
- tamper evident sealed packets
- do not use any opened or torn packets
Inactive Ingredient
Inactive ingredients
corn starch, hypromellose*, microcrystalline cellulose*, polyethylene glycol*, povidone*, propylene glycol*
*m ay contain
Otc - Questions
Questions or comments?1-800-634-76870
Medique Products Aspirin Label
Medique®
Aspirin
5 Grain (325 mg)
Pain Reliever/Fever Reducer
(NSAID)
This Package is for Households without Young Children.
Pull to Open
Aches/Fever • Aspirin 325 mg
200 Tablets (100 x 2)
Tamper Evident Unit Dose Packets
Medi-First Aspirin Label
100 Tablets
(50 x 2)
Medi-First®
Aspirin 5 Grain (325 mg)
Compare Acrive Ingredients to:
Genuine Bayer®
Registered Trademark of Pfizer Consumer
Pull To Open
Aches, Fever • Aspirin 325 mg
Pain Reliever/Fever Reducer (NSAID)
This Package is for Households without Young Children.
Tamper Evident Unit Dose Packets
Medi-First Plus Aspirin Label
250 Tablets
(125 x 2's)
Medi First® Plus
Aspirin
This Package is for Households without Young Children.
Pull To Open
Aspirin 325 mg (NSAID)
Pain Reliever/Fever Reducer
Compare active ingredient to:
Genuine Bayer®
Registered Trademark of Bayer Corporation
Tamper Evident Unit Dose Packets
Package Label.Principal Display Panel
Medique®
Aspirin
5 Grain (325 mg)
Pain Reliever/Fever Reducer
(NSAID)
This Package is for Households without Young Children.
Pull to Open
Aches/Fever • Aspirin 325 mg
200 Tablets (100 x 2)
Tamper Evident Unit Dose Packets
100 Tablets
(50 x 2)
Medi-First®
Aspirin 5 Grain (325 mg)
Compare Active Ingredients to:
Genuine Bayer®
Registered Trademark of Pfizer Consumer
Pull To Open
Aches, Fever • Aspirin 325 mg
Pain Reliever/Fever Reducer (NSAID)
This Package is for Households without Young Children.
Tamper Evident Unit Dose Packets
250 Tablets
(125 x 2's)
Medi First® Plus
Aspirin
This Package is for Households without Young Children.
Pull To Open
Aspirin 325 mg (NSAID)
Pain Reliever/Fever Reducer
Compare active ingredient to:
Genuine Bayer®
Registered Trademark of Bayer Corporation
Tamper Evident Unit Dose Packets
* Please review the disclaimer below.
