Aspirin ASPIRIN ADVANCE PHARMACEUTICAL INC. FDA Approved Uses temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds
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Substance Aspirin
Route
ORAL
Applications
PART343

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient (in each tablet) Aspirin 325 mg (NSAID) * *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive Ingredients croscarmellose sodium D&C Yellow #10 (Al-Lake) FD&C yellow #6 (Al-Lake) HPMC methacrylic acid copolymer polyethylene glycol propylene glycol PVP sodium lauryl sulfate starch stearic acid talc titanium dioxide
Strengths
325 mg
Quantities
100 tablets
Treats Conditions
Uses Temporarily Relieves Headache Menstrual Pain Muscle Pain Toothache Minor Pain Or Arthritis Pain And Fever Of Colds
Pill Appearance
Shape: round Color: orange Imprint: AP;011

Identifiers & Packaging

Container Type UNKNOWN
UPC
0017714011017
UNII
R16CO5Y76E
Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-011-01 – 100 Tablets a4b80d52-figure-01 a4b80d52-figure-02

Package Descriptions
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC: 17714-011-01 – 100 Tablets a4b80d52-figure-01 a4b80d52-figure-02

Overview

Uses temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds

Indications & Usage

Uses temporarily relieves headache menstrual pain muscle pain toothache minor pain or arthritis pain and fever of colds

Dosage & Administration

Directions DRINK A FULL GLASS OF WATER WITH EACH DOSE adults and children 12 years and over : 1-2 tablets every 4 hours while symptoms last, but not more than 12 tablets in 24 hours. Children under 12 years: ask a doctor

Warnings & Precautions
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 signs of Reye’s syndrome, a rare but serious illness. Allergy Alert: Aspirin may cause a severe allergic reaction which may include hives asthma (wheezing) shock facial swelling 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 takes other drugs containing prescription or nonprescription NSAIDs (ibuprofen, naproxen, others) takes more or for a longer time than directed have 3 or more alcoholic drinks every day while using this product. Do not use if you have ever had an allergic reaction to 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, lever cirrhosis, or kidney disease you are taking a diuretic you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout or arthritis taking any other drug under a doctor’s care for any serious condition Stop use and ask a doctor if you experiences 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 redness or swelling is present in the painful area any new symptoms appear ringing in the ears or a loss of hearing occurs 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.
Purpose

Purpose Pain reliever

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.

Questions

Questions or Comments Call 631-981-4600, 8.30am – 4.30 pm ET Monday-Friday TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Safer for your stomach than pain or Buffered Aspirin Manufactured by: Advance Pharmaceutical, Inc. Holtsville, NY 11742


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