OTC Aspirin Tablets

Manufacturer
Achlis Laboratories
Effective date
2019-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:54:27

Label at a glance#

ProductDr Pausins Low Dose Chewable Aspirin Orange Flavor
Active ingredientASPIRIN
Label structure56 sections

Storage and handling

Other Information store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) use by expiration date on package

Label contents#

Full prescribing information#

Dr. Pausin's Low Dose Aspirin

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Aspirin

OTC - PURPOSE SECTION

Purpose

Pain Reliever

Dr. Pausin's Low Dose Aspirin

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dr. Pausin's Low Dose Aspirin

WARNINGS SECTION

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 • shock • asthma (wheezing)

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

Dr. Pausin's Low Dose Aspirin

OTC - DO NOT USE SECTION

Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer

Dr. Pausin's Low Dose Aspirin

OTC - ASK DOCTOR SECTION

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

Dr. Pausin's Low Dose Aspirin

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • diabetes
  • gout
  • arthritis

Dr. Pausin's Low Dose Aspirin

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • a 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

  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

Dr. Pausin's Low Dose Aspirin

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Dr. Pausin's Low Dose Aspirin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Dr. Pausin's Low Dose Aspirin

DOSAGE & ADMINISTRATION SECTION

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Dr. Pausin's Low Dose Aspirin

STORAGE AND HANDLING SECTION

Other Information

  • store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
  • use by expiration date on package

Dr. Pausin's Low Dose Aspirin

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C yellow #10, FD&C blue #2, FD&C yellow #5, glyceryl monostearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, povidone K30, pregelatinized corn starch, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Dr. Pausin's Regular Strength Aspirin

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Regular Strength Aspirin

OTC - PURPOSE SECTION

Purpose

Pain Reliever

Dr. Pausin's Regular Strength Aspirin

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dr. Pausin's Regular Strength Aspirin

WARNINGS SECTION

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 ■ shock ■ asthma (wheezing)

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

Dr. Pausin's Regular Strength Aspirin

OTC - DO NOT USE SECTION

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

Dr. Pausin's Regular Strength Aspirin

OTC - ASK DOCTOR SECTION

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

Dr. Pausin's Regular Strength Aspirin

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Dr. Pausin's Regular Strength Aspirin

OTC - STOP USE SECTION

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 for more than 10 days
redness or swelling is present
any new symptoms appear
ringing in the ears or loss of hearing occurs

Dr. Pausin's Regular Strength Aspirin

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Dr. Pausin's Regular Strength Aspirin

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Dr. Pausin's Regular Strength Aspirin

DOSAGE & ADMINISTRATION SECTION

Directions

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

Dr. Pausin's Regular Strength Aspirin

STORAGE AND HANDLING SECTION

Other Information

store at 25°C (77°F); excursions permitted between

15-30°C (59-86°F)

use by expiration date on package

Dr. Pausin's Regular Strength Aspirin

INACTIVE INGREDIENT SECTION

Inactive ingredients D&C yellow #10, FD&C blue #2, FD&C yellow #5, glyceryl monostearate, methacrylic acid ethyl acrylate copolymer, microcrystalline cellulose, polyethylene glycol, polyvinyl acetate phthalate, polyvinyl alcohol, povidone K30, pregelatinized corn starch, silicon dioxide, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triethyl citrate

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - PURPOSE SECTION

Purpose
Pain Reliever

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

WARNINGS SECTION

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 ■ shock ■ asthma (wheezing)

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - DO NOT USE SECTION

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - ASK DOCTOR SECTION

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

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - STOP USE SECTION

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 for more than 10 days
  • redness or swelling is present
  • any new symptoms appear
  • ringing in the ears or loss of hearing occurs

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

DOSAGE & ADMINISTRATION SECTION

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

STORAGE AND HANDLING SECTION

Other Information

store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
use by expiration date on package

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, cherry, D&C red #27, dextrose, microcrystalline cellulose, mint, pregelatinized corn starch, saccharin sodium, silicon dioxide, talc

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - PURPOSE SECTION

Purpose

Pain Reliever

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

INDICATIONS & USAGE SECTION

Uses

for the temporary relief of minor aches and pains or as recommended by your doctor

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

WARNINGS SECTION

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 ■ shock ■ asthma (wheezing)

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (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

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - DO NOT USE SECTION

Do not use

if you have ever had an allergic reaction to any other pain reliever/fever reducer

this product for at least 7 days after tonsillectomy or oral surgery unless directed by a doctor

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - ASK DOCTOR SECTION

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

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout or arthritis

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - STOP USE SECTION

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 for more than 10 days
redness or swelling is present
any new symptoms appear
ringing in the ears or loss of hearing occurs

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

DOSAGE & ADMINISTRATION SECTION

Directions

drink a full glass of water with each dose
adults and children 12 years and over: take 4 to 8 tablets every 4 hours not to exceed 48 tablets in 24 hours unless directed by a doctor
children under 12 years: ask a doctor

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

STORAGE AND HANDLING SECTION

Other Information

store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F)
use by expiration date on package

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

INACTIVE INGREDIENT SECTION

Inactive ingredients acacia, anhydrous dextrose, FD&C yellow #6, maltodextrin, mint, modified corn starch, microcrystalline cellulose, orange, pregelatinized corn starch, saccharin sodium, silicon dioxide, talc

Dr. Pausin's Low Dose Aspirin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label BackLabel BackLabel Front SideLabel Front Side

Dr. Pausin's Regular Strength Aspirin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label BackLabel BackLabel FrontLabel Front

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label CartonLabel CartonLabel BottleLabel Bottle

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label CartonLabel CartonLabel BottleLabel Bottle

FDA-Initiated Inactive NDC Indexing#

Products#

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DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Ingredients#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16ef497f-b862-4fee-a682-84e35c5b0c9e5510ee23-0788-3beb-e054-00144ff8d46c2023-07-18WarningsExact identifier
spl set id: 5510ee23-0788-3beb-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.