ACETAMINOPHEN, ASPIRIN, CAFFEINE- acetaminophen, aspirin, caffeine tablet, film coated 
Proficient Rx LP

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5004-Rugby

Drug Facts

Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

Purposes

Pain reliever
Pain reliever aid

Uses

■ temporarily relieves minor aches and pains due to:
■ headache

■ muscular aches

■ a cold

■ arthritis
■ toothache

■ premenstrual and menstrual cramps

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)
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: ■ skin reddening ■ blisters ■ rash
If a skin reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: ■ with other drugs containing acetaminophen ■ more than 8 caplets in 24 hours, which is the maximum daily amount ■ 3 or more alcoholic drinks every day while
using this product
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 ■ take more or for a longer time than directed ■ 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
Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heartbeat.

Do not use

■ if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
■ with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

■ you have liver disease
■ 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 have asthma

■ you are taking a diuretic

Ask a doctor or pharmacist before use if you are
■ taking a prescription drug for diabetes, gout, or arthritis

■ taking any other drug or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

■ you experience any of the following signs of stomach bleeding:

■ feel faint

■ have bloody or black stools

■ vomit blood

■ have stomach pain that does not get better

■ an allergic reaction occurs. Seek medical help right away.
■ ringing in the ears or loss of hearing occurs

■ pain gets worse or lasts for more than 10 days

■ fever gets worse or lasts for more than 3 days

■ painful area is red or swollen

■ any new symptoms appear.
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 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.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

■ do not use more than directed
■ drink a full glass of water with each dose
■ adults and children 12 years and over:
■ take 2 caplets every 6 hours
■ do not take more than 8 caplets in 24 hours
■ children under 12 years: ask a doctor

Other information

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

■ use by expiration date on package

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Questions or comments?

1-800-645-2158

RETAIN THIS CARTON FOR COMPLETE PRODUCT INFORMATION

Distributed by: RUGBY® LABORATORIES, Livonia, MI 48152
www.rugbylaboratories.com

Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320

†This product is not manufactured or distributed by GlaxoSmithKline, owner of the registered trademark Excedrin®

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

Pain Reliever Plus

NDC 82804-008-60
Compare to the active ingredients in Excedrin® Extra Strength Caplets†

Acetaminophen, Aspirin (NSAID)* and Caffeine

250mg/250mg/65mg

Pain Reliever/Pain Reliever Aid

NOT FOR HOUSEHOLDS WITH YOUNG CHILDREN

60 Caplets

82804-008-60
ACETAMINOPHEN, ASPIRIN, CAFFEINE 
acetaminophen, aspirin, caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82804-008(NDC:0536-1326)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
POLYDEXTROSE (UNII: VH2XOU12IE)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
STARCH, CORN (UNII: O8232NY3SJ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize17mm
FlavorImprint Code 2793
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82804-008-3030 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2023
2NDC:82804-008-6060 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2023
3NDC:82804-008-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01306/03/2021
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIBusiness Operations
Proficient Rx LP079196022REPACK(82804-008) , RELABEL(82804-008)

Revised: 11/2023
Document Id: af8b30a0-7a56-4557-8404-cc8059fcd6bc
Set id: af8b30a0-7a56-4557-8404-cc8059fcd6bc
Version: 1
Effective Time: 20231101
 
Proficient Rx LP