MedPath

Headache Relief

Quality Choice 44-334B

Approved
Approval ID

17216bf3-bed0-4d7a-994e-76a0e4c79c5c

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

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
NDC Product Code83324-331
Application NumberM013
Product Classification
M
Marketing Category
C200263
G
Generic Name
Acetaminophen, Aspirin, Caffeine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (13)

ACETAMINOPHENActive
Quantity: 250 mg in 1 1
Code: 362O9ITL9D
Classification: ACTIB
ASPIRINActive
Quantity: 250 mg in 1 1
Code: R16CO5Y76E
Classification: ACTIB
CAFFEINEActive
Quantity: 65 mg in 1 1
Code: 3G6A5W338E
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/2/2025

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](/dailymed/image.cfm?name=quality- choice-44-334b-1.jpg&id=895885)

Quality Choice 44-334B

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/2/2025

Uses

  • temporarily relieves minor aches and pains due to:
    • toothache
    • arthritis
    • muscular aches
    • headache
    • a cold
    • premenstrual and menstrual cramps

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/2/2025

Purpose

Pain reliever
Pain reliever
Pain reliever aid

WARNINGS SECTION

LOINC: 34071-1Updated: 9/2/2025

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:

  • 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

LOINC: 34068-7Updated: 9/2/2025

Directions

*do not take more than directed

  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 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

LOINC: 44425-7Updated: 9/2/2025

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: 9/2/2025

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/2/2025

Questions or comments?

1-800-426-9391

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/2/2025

Active ingredients (in each caplet)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID*)
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug

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