Headache Relief
Quality Choice 44-334B
17216bf3-bed0-4d7a-994e-76a0e4c79c5c
HUMAN OTC DRUG LABEL
Sep 2, 2025
Chain Drug Marketing Association, Inc.
DUNS: 011920774
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Acetaminophen, Aspirin, Caffeine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (13)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal display panel
QC®
QUALITY
CHOICE
NDC 83324-331-24
Compare to the Active
Ingredients in Excedrin®
Extra Strength Headache†
Extra Strength
Headache Relief
Acetaminophen, Aspirin (NSAID) & Caffeine
Pain Reliever/Pain Reliever Aid
24 Coated Caplets
Actual Size
† This product is not manufactured or distributed by Haleon CH SARL,
owner of the registered trademark Excedrin® Extra Strength Headache.
50844 ORG022433408
Distributed by CDMA, Inc.
Novi, MI 48375
www.qualitychoice.com
Questions: 800-935-2362
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Quality Choice 44-334B
INDICATIONS & USAGE SECTION
Uses
- temporarily relieves minor aches and pains due to:
- toothache
- arthritis
- muscular aches
- headache
- a cold
- premenstrual and menstrual cramps
OTC - PURPOSE SECTION
Purpose
Pain reliever
Pain reliever
Pain reliever aid
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:
- shock
- hives
- facial swelling
- 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
- more than 4,000 mg of acetaminophen in 24 hours
- 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 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 heartbeat.
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.
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 asthma
- 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 diabetes, gout, or 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:
- 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 for more than 10 days
- fever gets worse or lasts for more than 3 days
- redness or swelling is present
- any new symptoms appear
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. 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
*do not take 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
STORAGE AND HANDLING SECTION
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
Inactive ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
OTC - QUESTIONS SECTION
Questions or comments?
1-800-426-9391
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug