Advanced Aspirin
FDA Label NDC 67060-232

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advanced First Aid, Inc. for the product Advanced Aspirin (NDC 67060-232). 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 - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

ACTIVE INGREDIENT IN EACH TABLET- ASPIRIN 325 MG

Otc - Purpose

PAIN RELIEVER/FEVER REDUCER

Indications & Usage

Uses:

temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis•

muscle pain • pain and fever of colds • toothache • temporarily reduces fever

Warnings

Uses:

temporarily relieves minor pain due to: • headache • menstrual pain • minor pain of arthritis

muscle pain • pain and fever of colds • 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

Stomach Bleeding Warning:

This product contains nonsteroidal anti-inflammatory drugs (NSAIDs),

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 prescription or nonprescription containing an NSAID [aspirin, ibuprofen, naproxen, or

others]

• take more or for a longer time than directed.

Do not use:

• if you are allergic to aspirin or any other pain reliever/fever reducer

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 a sodium-restricted diet

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:

• an allergic reaction occurs. Seek medical help right away. • you

experience any of the following signs of stomach bleeding:

• you feel faint, vomit blood, or have bloody

or black stools

• redness or swelling is present • pain gets worse or lasts more than 10 days • fever lasts

more than 3 days

• new symptoms occur • ringing in the ears or a loss of hearing occurs

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding baby,

ask a health professional

before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS

SPECIFIC-ALLY 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. Prompt medical attention is critical for

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

Dosage & Administration

Directions:

Drink a full glass of water with each dose

Adults and children 12 years OR OLDER :TAKE 2 TABLETS EVERY 4-6 HOURS AS needed, do not exceed 12 tablets in

24 hours, or as directed by a doctor.

Children under 12 YEARSOF AGE

• consult a doctor

Inactive Ingredient

Inactive Ingredients:

microcrystalline cellulose,

povidone, pregelatinized starch

Package Label.Principal Display Panel

Aspirin Carton (Adv 1st Aid Aspirin Carton)

Aspirin Carton (Adv 1st Aid Aspirin Carton)

Image Description (Adv 1st Aid Aspirin Packet)

Image Description (Adv 1st Aid Aspirin Packet)

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