Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg

Manufacturer
Health Pharma USA LLC
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
weekly-update
Hydrated at
2026-07-17 21:43:51

Label at a glance#

ProductAcetaminophen 250 mg Aspirin 250 mg Caffeine 65 mg
Active ingredientCAFFEINE, ASPIRIN
Label structure15 sections

Indications and uses

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

Dosage and administration

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 tablets every 6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each caplet)

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each caplet) Purpose

Acetaminophen 250 mg.......................................................................................................Pain reliever
Aspirin 250 mg (NSAID)*....................................................................................................Pain reliever
Caffeine 65 mg..............................................................................................................Pain reliever aid

*nonsteroidal anti-inflammatory drug

Purpose

OTC - PURPOSE SECTION

Pain reliever
Pain reliever
Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

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

Warning

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 ■ shock ■ facial swelling ■ asthma (wheezing).
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 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 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

OTC - DO NOT USE SECTION

Do not use ■if you 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if■ 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 your doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

ask your 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 doctor if

OTC - STOP USE SECTION

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. ■ any new symptoms appear ■ 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

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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
(1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not
notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

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 tablets every 6 hours ■ do not take more than 8 tablets in 24 hours ■ children under 12
years: ask a doctor

Other Information

OTHER SAFETY INFORMATION

Other Information
■ Store at controlled room temperature 20°-25°C (68°-77°F).
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients:Microcrystalline Cellulose, Polyethylene glycol, Polyvinyl pyrrolidinone,
Pregelatinized Starch, Starch, Stearic Acid powder, colloidal Silicon Dioxide, Talc, Hypromellose,Purified water

Questions or comments?

OTC - QUESTIONS SECTION

Questions or comments?
Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

71679-307-00-Bulk Label71679-307-00-Bulk Label71679-307-03-ES Headache Relief-APAP-Aspirin-Caffeine-300s-7.5x3-300cc Label71679-307-03-ES Headache Relief-APAP-Aspirin-Caffeine-300s-7.5x3-300cc Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371679307036GTIN-13: 0371679307036
EAN-13: 0371679307036
GTIN-12: 371679307036
UPC-A: 371679307036
GTIN storage (14 digits): 00371679307036
71679-307-03-ES Headache Relief-APAP-Aspirin-Caffeine-300s-7.5x3-300cc Label.jpg
QR code linkQR Codeqrco.de/bd4xHA71679-307-03-ES Headache Relief-APAP-Aspirin-Caffeine-300s-7.5x3-300cc Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71679-30771679-307-00, 71679-307-03

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
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
ndc (package): 71679-307-00
ndc (package): 71679-307-03
ndc (product): 71679-307
ndc11 (package): 71679030700
ndc11 (package): 71679030703
spl id: 561393c6-f876-f94a-e063-6294a90a151c
spl set id: 3590d417-272b-ae4d-e063-6394a90a5dc6

Reported adverse events (FAERS/openFDA)#

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