Pain Aid ESF

Manufacturer
Cintas Corporation | Ultra Seal Corporation | Ultratab Laboratories, Inc.
Effective date
2021-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:46

Label at a glance#

ProductPain Aid ESF
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each tablet)  Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

OTC - PURPOSE SECTION

Purpose-Pain reliever, Fever Reducer

INDICATIONS & USAGE SECTION

Uses
■ temporarily relieves pain due to:
■ headache ■ muscular aches ■ colds ■ flu
■ temporarily reduces fever

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults: take 2 tablets every 6 hours, not more than 8 tablets in

24 hours

  • children under 12 years: ask a doctor

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 ■ asthma (wheezing) ■ shock
Liver warning: This product contains acetaminophen. Severe
liver damage may occur if you take ■ more than 8 tablets in 24
hours, which is the maximum daily amount
■ with other drugs containing acetaminophen
■ 3 or more alcoholic drinks every day while using this product
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
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 heart beat.
Do not use
■ if you have ever had an allergic reaction to 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.
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:
■ feel faint ■ vomit blood ■ have bloody or black stools
■ have stomach pain that does not get better
■ ringing in the ears or 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 in the painful area
■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding baby, ask a health professional  
before use

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.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

INACTIVE INGREDIENT SECTION

Inactive ingredients cellulose*, hydroxypropyl
methylcellulose, maltodextrin*, polyethylene glycol, povidone,
propylene glycol*, sodium lauryl sulfate*, sodium starch
glycolate, starch, stearic acid, titanium dioxide
*contains one or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MM1ESF 250 BoxESF 250 Box ESF 250 BoxESF 250 Box1

Products#

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DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-04742961-047-01, 42961-047-02, 42961-047-03, 42961-047-04

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
2c292187-51d0-4804-8e7e-03e28f6593510535e32b-2323-4f75-8a65-1f3d90de829d2022-12-30WarningsExact identifier
spl set id: 0535e32b-2323-4f75-8a65-1f3d90de829d

Reported adverse events (FAERS/openFDA)#

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