Medicine guide

Acetaminophen, Aspirin, Caffeine

250 mg + 250 mg + 65 mg · Tablet, Film Coated

Available without prescription
Central Nervous System Stimulant

Active substance: Acetaminophen, Aspirin, Caffeine
Used in: Muscles, joints and bones
Made by: LEADER/ Cardinal Health 110, Inc.
Source: Official label

Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.

At a glance

Quoted from the official label · 2025-02-11

What it is

Pain reliever Pain reliever aid

Used for

Headache
Muscular aches
A cold
Arthritis
Toothache

+1 more

How to take it

Adults and children 12 years and over:: take 2 caplets every 6 hours

do not take more than 8 caplets in 24 hours

Full directions ↓

Do not take it if

If you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer

All warnings ↓

Good to know

Sold without a prescription
FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02

76other products contain Acetaminophen, Aspirin, Caffeine — compare makers, forms and strengths

Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed

What it is for

temporarily relieves minor aches and pains due to:

headache
muscular aches
a cold
arthritis
toothache
premenstrual and menstrual cramps

From the official label · 2025-02-11 · DailyMed

Do not take it if

if you have 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.

Quoted from the official label, section “OTC — Do Not Use”.

How to take it

These directions are for this exact strength and form. Another one is different.

do not use 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

Quoted from the official label, section “Dosage & Administration”.

Ask a doctor first 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

Quoted from the official label, section “OTC — Ask Doctor”.

Ask a pharmacist first 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

Quoted from the official label, section “OTC — Ask Doctor/Pharmacist”.

Stop and get help 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.
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
any new symptoms appear. These could be signs of a serious condition.

Quoted from the official label, section “OTC — Stop Use”.

Other 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
shock
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:
with other drugs containing acetaminophen
more than 8 caplets in 24 hours, which is the maximum daily amount
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
take more or for a longer time than directed
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 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
Ask a doctor before use if
you are taking a diuretic Ask a doctor or pharmacist before use if you are
Stop use and
ask a doctor if
feel faint
vomit blood
any new symptoms appear. These could be signs of a serious condition. 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. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

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.

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for
adults as well as for children even
if you do not notice any signs or symptoms.

Quoted from the official label, section “Overdosage”.

Other information

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
use by expiration date on package

Quoted from the official label, section “OTC — Other Information”.

What kind of medicine it is

Pain reliever Pain reliever aid

Quoted from the official label, section “OTC — Purpose”.

Other ingredients

Relevant if you react to a dye, a preservative, lactose or gluten.

hypromellose, maltodextrin, microcrystalline cellulose, polydextrose, polyvinylpyrrolidone, pregelatinized starch, silica, starch, stearic acid, talc, titanium dioxide, triglycerides

Quoted from the official label, section “Inactive Ingredients”.

Questions about this product

1-800-231-4670

Quoted from the official label, section “OTC — Questions”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Titanium dioxidetitanium dioxideA whitening agent no longer allowed in food in the EU (E171).

Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.

Every version of this medicine (87)

The same active substance, strength and kind of form, from every company that sells it — with what each label lists.

Showing 80 of 80 (the first 80 are listed)

Details

Made by	LEADER/ Cardinal Health 110, Inc.
Active substance	Acetaminophen, Aspirin, Caffeine
Used in	Muscles, joints and bones
Strength	250 mg + 250 mg + 65 mg
Form	Tablet, Film Coated
Route	Oral
Packs	1 BOTTLE in 1 CARTON / 100 TABLET, FILM COATED in 1 BOTTLE
NDC	70000-0066

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

4 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Tablet, Film Coated4 products
- 65 mg + 250 mg + 250 mg
- 250 mg + 250 mg + 65 mg
- 250 mg + 65 mg + 250 mg2
  250 mg + 65 mg + 250 mg · 2 companies
  - NuCare Pharmaceuticals,Inc.
  - Proficient Rx LP

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Acetaminophen, Aspirin, Caffeine