Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2d5393e3-335e-6133-e054-00144ff88e88
Route
ORAL
Published
Effective Date 2016-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (325 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromelloses Mineral Oil Starch, Corn Titanium Dioxide Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance
Imprint: TCL;011 Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-25

Description

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

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

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

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis pain
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces fever.

Section 42229-5

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.

Section 50565-1

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

Section 51945-4

Section 53414-9

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.

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
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
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

When Using This Product
  • take with food or milk if stomach upset occurs
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
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
Active Ingredient (in Each Tablet)

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are
  • under a doctor's care for any serious condition
  • taking any other drug

Structured Label Content

Uses

Temporarily relieves minor aches and pains associated with

  • headache
  • minor arthritis pain
  • common cold
  • menstrual cramps
  • muscular aches
  • backache
  • toothache

Temporarily reduces fever.

Section 42229-5 (42229-5)

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.

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Pain reliever/fever reducer

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
Do Not Use (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
Other Information (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 (Inactive ingredients)

corn starch, croscarmellose sodium, hypromellose, microcrystalline cellulose, mineral oil, titanium dioxide

When Using This Product (When using this product)
  • take with food or milk if stomach upset occurs
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 are taking a diuretic
  • you have asthma
Stop Use and Ask A Doctor If (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
Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Aspirin (NSAID*) 325 mg

*nonsteroidal anti-inflammatory drug

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • under a doctor's care for any serious condition
  • taking any other drug

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)