MedPath

Aspirin

Rugby 44-600A

Approved
Approval ID

29214eec-860c-43f0-83c6-9ed5a9f530af

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 22, 2025

Manufacturers
FDA

Preferred Pharmaceuticals Inc.

DUNS: 791119022

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Aspirin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code68788-4028
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Aspirin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2025
FDA Product Classification

INGREDIENTS (19)

ASPIRINActive
Quantity: 81 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLYDEXTROSEInactive
Code: VH2XOU12IE
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
DIMETHICONE, UNSPECIFIEDInactive
Code: 92RU3N3Y1O
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/22/2025

Principal Display Panel

Rugby®

Relabeled By: Preferred Pharmaceuticals Inc.

NDC 0536-1234-41

Compare to the active ingredient
in Bayer® Low Dose Aspirin†

low dose aspirin

** Aspirin 81 mg**
Pain Reliever**(NSAID)**

120 Enteric Coated Tablets

safety coated

Actual Size

†This product is not manufactured or distributed by Bayer
AG, owner of the registered trademark Bayer® Low Dose
Aspirin. 50844 REV0122B60032

TAMPER EVIDENT: DO NOT USE IF
** IMPRINTED SAFETY SEAL UNDER**
** CAP IS BROKEN OR MISSING**

Rev. 04/25 R-17 Re-order No. 370718

Aspirin Tab 81mg Low Dose Enteric Coated

Rugby 44-600A

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/22/2025

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.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/22/2025

Active ingredient (in each tablet)

Aspirin 81 mg (NSAID)*
*nonsteroidal anti-inflammatory drug

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/22/2025

Purpose

Pain reliever

WARNINGS SECTION

LOINC: 34071-1Updated: 9/22/2025

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 an NSAID, which may cause severe stomach bleeding. The chance is higher if you

take more or for a longer time than directed  

take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]

have had stomach ulcers or bleeding problems  

take a blood thinning (anticoagulant) or steroid drug 

are age 60 or older  

have 3 or more alcoholic drinks every day while using this product

Do not use

if you are allergic to aspirin or any other pain reliever/fever reducer  

if you have ever had an allergic reaction to this product or any of its ingredients  

Ask a doctor before use if

you have asthma

stomach bleeding warning applies to you

you have a history of stomach problems, such as heartburn

you are taking a diuretic

you have high blood pressure, heart disease, liver cirrhosis, or kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug for

gout 

diabetes 

arthritis  

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: 

vomit blood  

have bloody or black stools 

feel faint  

have stomach pain that does not get better  

ringing in the ears or a loss of hearing occurs  

pain gets worse or lasts more than 10 days  

fever gets worse or lasts more than 3 days  

redness or swelling is present  

new symptoms occur  

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely 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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/22/2025

Directions

**do not take more than directed**   

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: do not use unless directed by a doctor  

STORAGE AND HANDLING SECTION

LOINC: 44425-7Updated: 9/22/2025

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)  

see end flap for expiration date and lot number  

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/22/2025

Inactive ingredients

corn starch, D&C yellow #10, FD&C yellow #6, hypromellose, methacrylic acid, microcrystalline cellulose, polydextrose, polyethylene glycol, shellac wax, silica, simethicone, sodium bicarbonate, sodium lauryl sulfate, talc, titanium dioxide, triacetin, triethyl citrate

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/22/2025

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1-800-645-2158

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Aspirin - FDA Drug Approval Details