Indications and uses
temporarily relieves minor aches and pains due to: a cold toothache headache muscular aches premenstrual and menstrual cramps arthritis
pain reliever
- Manufacturer
- Rite Aid Corporation | LNK International, Inc.
- Effective date
- 2020-09-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:15:43
Label at a glance#
Productpain reliever extra strength
Active ingredientACETAMINOPHEN, ASPIRIN, CAFFEINE
Label structure9 sections
Dosage and administration
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
Storage and handling
store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients (in each caplet)
Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg
*nonsteroidal anti-inflammatory drug
Purpose
Pain reliever
Pain reliever
Pain reliever aid
Uses
- temporarily relieves minor aches and pains due to:
- a cold
- toothache
- headache
- muscular aches
- premenstrual and menstrual cramps
- arthritis
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
- facial swelling
- hives
- 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
- 3 or more alcoholic drinks every day while using this product
- more than 4,000 mg in 24 hours, which is the maximum daily amount
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
- 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
- are age 60 or older
- 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
Ask a doctor before use if
- you have liver disease
- you have asthma
- you are taking a diuretic
- 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
Ask a 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 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,
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 adults as well as for children even if you do not notice any signs or symptoms.
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 caplets every 6 hours
- do not take more than 8 caplets in 24 hours
- children under 12 years: ask a doctor
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 ingredients
corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Questions or comments?
1-800-426-9391
Principal Display Panel
RITE
AID
PHARMACY®
**Compare to the active ingredients in Excedrin® Extra Strength
EXTRA STRENGTH
pain reliever
acetaminophen 250 mg,
aspirin (NSAID) 250 mg & caffeine 65 mg
pain reliever • pain reliever aid
200 COATED CAPLETS
ACTUAL SIZE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED
SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
**This product is not manufactured or distributed by Novartis AG, owner
of the registered trademark Excedrin® Extra Strength.
50844 REV0117A33406
DISTRIBUTED BY: RITE AID
30 HUNTER LANE
CAMP HILL, PA 17011
RITE
AID®
SATISFACTION
GUARANTEED
IF YOU’RE NOT
SATISFIED, WE’LL
HAPPILY REFUND
YOUR MONEY.
Products#
Every source-derived product name is available through these pages.
- pain reliever extra strength
- acetaminophen, aspirin, caffeine
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- STARCH, CORN
- CROSPOVIDONE, UNSPECIFIED
- HYPROMELLOSE, UNSPECIFIED
- MICROCRYSTALLINE CELLULOSE
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- SODIUM LAURYL SULFATE
- STEARIC ACID
- TITANIUM DIOXIDE
- SODIUM STARCH GLYCOLATE TYPE A POTATO
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11822-0334 | 11822-0334-6 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 4bc7663a-41db-40e3-8bf0-7d7265c65807 | 6a8ecd89-30cc-420c-ba54-798ec415aaa8 | 2020-09-03 | Warnings | 4bc7663a-41db-40e3-8bf0-7d7265c65807 6a8ecd89-30cc-420c-ba54-798ec415aaa8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.