DR PAUSINS LOW DOSE CHEWABLE ASPIRIN ORANGE FLAVOR- aspirin tablet, chewable DR PAUSINS LOW DOSE ASPIRIN- aspirin tablet, coated DR PAUSINS LOW DOSE CHEWABLE ASPIRIN CHERRY FLAVOR- aspirin tablet, chewable DR PAUSINS ASPIRIN- aspirin tablet, coated

Dr Pausins Aspirin by

Drug Labeling and Warnings

Dr Pausins Aspirin by is a Otc medication manufactured, distributed, or labeled by Achlis Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Dr. Pausin's Low Dose Aspirin

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Aspirin

Purpose

Pain Reliever

Dr. Pausin's Low Dose Aspirin

Uses

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

Dr. Pausin's Low Dose Aspirin

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

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

Dr. Pausin's Low Dose Aspirin

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

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

• diabetes
• gout
• arthritis

Dr. Pausin's Low Dose Aspirin

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

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

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

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

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 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

Active ingredient (in each caplet)

Aspirin 325 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Regular Strength Aspirin

Purpose

Pain Reliever

Dr. Pausin's Regular Strength Aspirin

Uses

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

Dr. Pausin's Regular Strength Aspirin

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

Do not use

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

Dr. Pausin's Regular Strength Aspirin

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

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

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

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

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

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

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 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

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

Purpose
Pain Reliever

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

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

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

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

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

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

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

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

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

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

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 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

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

Purpose

Pain Reliever

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

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

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

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

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

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

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

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

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

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

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 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

Dr. Pausin's Regular Strength Aspirin

Dr. Pausin's Low Dose Chewable Aspirin Cherry Flavor

Dr. Pausin's Low Dose Chewable Aspirin Orange Flavor

INGREDIENTS AND APPEARANCE

DR PAUSINS LOW DOSE CHEWABLE ASPIRIN  ORANGE FLAVOR
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71476-102
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
TALC (UNII: 7SEV7J4R1U)
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ORANGE (UNII: 5EVU04N5QU)
MINT (UNII: FV98Z8GITP)
ACACIA (UNII: 5C5403N26O)

Product Characteristics
Color	orange	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71476-102-31	3 in 1 CARTON	10/10/2017
1	NDC: 71476-102-36	36 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/10/2017

DR PAUSINS LOW DOSE ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71476-103
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)

Product Characteristics
Color	yellow	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71476-103-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/10/2017

DR PAUSINS LOW DOSE CHEWABLE ASPIRIN  CHERRY FLAVOR
aspirin tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71476-101
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	81 mg

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CHERRY (UNII: BUC5I9595W)
ACACIA (UNII: 5C5403N26O)
MINT (UNII: FV98Z8GITP)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
D&C RED NO. 27 (UNII: 2LRS185U6K)
TALC (UNII: 7SEV7J4R1U)

Product Characteristics
Color	pink	Score	no score
Shape	ROUND	Size	8mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71476-101-31	3 in 1 CARTON	10/10/2017
1	NDC: 71476-101-36	36 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/10/2017

DR PAUSINS ASPIRIN 
aspirin tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71476-104
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE K30 (UNII: U725QWY32X)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)

Product Characteristics
Color	yellow	Score	no score
Shape	OVAL	Size	15mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71476-104-50	500 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part343	10/10/2017

Labeler - Achlis Laboratories (078437206)