ADVANCED PAIN RELIEVER

Manufacturer
ADVANCED FIRST AID, INC. | ULTRA SEAL CORPORATION | ULTRA TAB LABORATORIES, INC.
Effective date
2019-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:17:09

Label at a glance#

ProductADVANCED PAIN RELIEVER
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

PAIN RELIEVER/FEVER REDUCER WITH ADJUVANT

INDICATIONS & USAGE SECTION

Uses:

temporarily relieves minor aches and pains associated with:

• headaches • colds • toothache • minor arthritis pain • muscular aches • menstrual cramps • backache

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:

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.

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 an 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 with other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen or others)

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

• you 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 medcations, foods or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionally, rapid heart beat.

Do not use:

• with any other product containing acetaminophen (prescription or nonprescription) this will provide more than the recommended dose (overdose) of acetaminophen and could cause serious health concerns

• with any other pain reliever/fever reducer

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

• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

Ask doctor before using if you have:

• stomach problems (such as heartburn, upset stomach or stomach pain)

• stomach bleeding warning applies to you

• gastric ulcers 

• bleeding problems

• you have athma, high blood pressure, heart disease, liver disease, or kidney disease

• you are taking a diuretic

Ask a doctor or pharmacist before use if

you are taking a prescription drug for: • anticoagulation (thinning of blood) • diabetes • gout • arthritis

• under a doctor's care for any serious condition

• taking any other drug

When using this product do not exceed recommended dose.

Stop use and ask a doctor if:

• ringing in the ears or loss of hearing occurs

• pain or fever persists or gets worse

• new symptoms occur

• redness or swelling is present

• you feel faint, vomit blood or have bloody or black stools, have stomach pain that does not get better. These are signs of stomach bleeding.

• an allerginc reaction occurs

Seek medical help right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding baby, ask a health professional before use. IT IS ESPECIALLY IMPORTANT NOT TO USE ASPIRIN

DURING THE LAST 3 MONTHS OF PREGNANCY UNLESS SPECIFICALLY DIRECTED TO DO SO BY A DOCTOR BECAUSE IT

MAY CAUSE PROBLEMS IN THE UNBORN CHILD OR COMPLICATIONS DURING DELIVERY.

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age and older:Take 2 tablets every 6 hours as needed, with a full glass of water. Do not exceed 8 tablets in any 24 hour period.

Children under 12 years: Ask a doctor.

INACTIVE INGREDIENT SECTION

hypromellose*, maltodextrin*, microcrystalline cellulose, polyethylene glycol*, povidone, sodium starch glycolate, starch, stearic acid, titanium dioxide*

*contains one or more of these ingredients

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ADVANCED PAIN RELIEVER BOXADVANCED PAIN RELIEVER BOXADVANCED PAIN RELIEVER BOXADVANCED PAIN RELIEVER BOX

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67060-11767060-117-67

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
4fc17ba7-d0e3-4a09-8bfb-2133e262414b8cb63e33-5688-418f-8aa4-470b6fb472822019-10-10WarningsExact identifier
spl set id: 8cb63e33-5688-418f-8aa4-470b6fb47282

Reported adverse events (FAERS/openFDA)#

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