Regular Strength Enteric Anti-inflammatory/analgesic Aspirin

Regular Strength Enteric Anti-inflammatory/analgesic Aspirin
SPL v1
SPL
SPL Set ID 3a3cd47e-1ee5-4e26-baa3-da2786c1a595
Route
ORAL
Published
Effective Date 2015-01-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Croscarmellose Sodium Hydroxypropyl Cellulose (type H) Starch, Corn D&c Yellow No. 10 Hypromellose Phthalate (31% Phthalate, 40 Cst) Cellulose, Microcrystalline Polysorbate 80 Mineral Oil Polyethylene Glycol 400 Titanium Dioxide Fd&c Yellow No. 6

Identifiers & Packaging

Pill Appearance
Imprint: A Shape: round Color: orange Size: 8 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-11-01

Description

Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

How Supplied

Aspirin is supplied by State of Florida DOH Central Pharmacy as follows: NDC Strength Quantity/Form Color Source Prod. Code 53808-1028-1 325 MG 30 Tablets in a Blister Pack ORANGE 0603-0168 This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 USA


Medication Information

Purpose

Pain reliever

How Supplied

Aspirin is supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1028-1 325 MG 30 Tablets in a Blister Pack ORANGE 0603-0168

This Product was Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

USA

Description

Aspirin 325 mg (NSAID*) *nonsteroidal anti-inflammatory drug

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

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

Directions

■ drink a full glass of water with each does ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor

Do Not Use

if you are allergic to aspirin or other pain relievers/fever reducers

Package Label

Label Image for 53808-1028

325mg

Other Information

■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing

You may report serious side effects to 1-888-952-0050

Inactive Ingredients

Acetylated monoglycerides, corn starch, croscarmellose sodium, D&C Yellow 10, FD&C Yellow #6, hypromellose, hypromellose phthalate, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium doxide

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 have asthma ■ you are taking a diuretic

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: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days

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 delivery.

Keep Out of Reach of Children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Tablet)

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are

taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis


Structured Label Content

Uses (USES)

for the temporary relief of minor aches and pains or as recommended by your doctor. Because of its delayed action, this product will not provide fast relief of headaches or other symptoms needing immediate relief.

Purpose (PURPOSE)

Pain reliever

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

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

Directions

■ drink a full glass of water with each does ■ adults and children 12 years and over: take 1 to 2 tablets every 4 hours not to exceed 12 tablets in 24 hours unless directed by a doctor ■ children under 12 years: consult a doctor

Do Not Use (Do not use)

if you are allergic to aspirin or other pain relievers/fever reducers

How Supplied

Aspirin is supplied by State of Florida DOH Central Pharmacy as follows:

NDC Strength Quantity/Form Color Source Prod. Code
53808-1028-1 325 MG 30 Tablets in a Blister Pack ORANGE 0603-0168

This Product was Repackaged By:

State of Florida DOH Central Pharmacy

104-2 Hamilton Park Drive

Tallahassee, FL 32304

USA

Package Label (PACKAGE LABEL)

Label Image for 53808-1028

325mg

Other Information (Other information)

■ store at room temperature ■ do not use if imprinted safety seal under cap is broken or missing

You may report serious side effects to 1-888-952-0050

Inactive Ingredients (Inactive ingredients)

Acetylated monoglycerides, corn starch, croscarmellose sodium, D&C Yellow 10, FD&C Yellow #6, hypromellose, hypromellose phthalate, microcrystalline cellulose, mineral oil, polyethylene glycol 400, polysorbate 80, titanium doxide

Ask A Doctor Before Use If (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 have asthma ■ you are taking a diuretic

Stop Use and Ask A Doctor If (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: feel faint, vomit blood, have bloody or black stools, have stomach pain that does not get better ■ new symptoms occur ■ redness or swelling is present ■ ringing in the ears or loss of hearing occurs ■ pain gets worse or lasts for more than 10 days

If Pregnant Or Breast Feeding, (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 delivery.

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.

Active Ingredient (in Each Tablet) (ACTIVE INGREDIENT (IN EACH TABLET))

Aspirin 325 mg (NSAID*)

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking a prescription drug for ■ anticoagulation (thinning the blood) ■ diabetes ■ gout ■ arthritis


Advanced Ingredient Data


Raw Label Data

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