Version
v3
Effective date
September 24, 2025
Original packager
Yes
Sections captured
16
Identifiers
- Document ID
- b7379830-65bc-4257-8915-b0f14f506e93
- Set ID
- 1269d069-afaf-4ca5-b369-f74249a348db
- Application numbers
- M013
- Product NDCs
- 42961-234
- Package NDCs
- 42961-234-01, 42961-234-02, 42961-234-03, 42961-234-04, 42961-234-05
- Original packager NDCs
- —
Names & Manufacturers
- Brand names
- Xpect Pain Away Extra Strength
- Generic names
- ACETAMINOPHEN ASPIRIN CAFFEINE
- Manufacturer names
- Cintas Corporation
- Product types
- HUMAN OTC DRUG
Substances & Pharmacology
- Substance names
- ACETAMINOPHEN, ASPIRIN, CAFFEINE
- Routes
- ORAL
- Pharmacologic class (PE)
- Central Nervous System Stimulation [PE], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE]
- Pharmacologic class (EPC)
- Central Nervous System Stimulant [EPC], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC]
- Pharmacologic class (CS)
- Anti-Inflammatory Agents, Non-Steroidal [CS], Xanthines [CS]
- Mechanism of action
- Cyclooxygenase Inhibitors [MoA]
Other identifiers
- NUI
- M0001335, M0023046, N0000000160, N0000008832, N0000008836, N0000175578, N0000175722, N0000175729, N0000175739, N0000175790
- RxCUI
- 308297
- UNII
- 362O9ITL9D, 3G6A5W338E, R16CO5Y76E
- UPC
- —
Structured Label Sections
Active Ingredient (1)
Sequence 1
Active ingredients (in each tablet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Caffeine 65 mg *nonsteroidal anti-inflammatory drug
Ask Doctor (1)
Sequence 1
Ask a doctor before use if you have liver disease you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
Ask Doctor Or Pharmacist (1)
Sequence 1
Ask a doctor or pharmacist before use if you are taking a precription drug for diabetes, gout, or arthritis taking any other drug or are under a doctor's care for any serious condition
Do Not Use (1)
Sequence 1
Do not use 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 if you have ever had an allergic reaction to this product or any of its ingredients
Dosage And Administration (1)
Sequence 1
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 tablets every 6 hours. Do not take more than 8 tablets in 24 hours. children under 12 years: ask a doctor
Inactive Ingredient (1)
Sequence 1
Inactive ingredients corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide
Indications And Usage (1)
Sequence 1
Uses temporarily relieves minor aches and pains due to: • a cold • toothache • headache • muscular aches • arthritis • premenstrual and menstrual cramps
Keep Out Of Reach Of Children (1)
Sequence 1
Keep out of reach of children. In case of accidental 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.
Other Safety Information (1)
Sequence 1
Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see packet for expiration date and lot number
Package Label Principal Display Panel (2)
Sequence 1
Principal Display Panel - 42961-234-04 †Compare to the active ingredients of Excedrin® EXTRA STRENGTH PAIN AWAY® Active Ingredients: Acetaminophen Aspirin (NSAID) Caffeine Pain Reliever / Pain Reliever Aid Relief from headaches Contains caffeine Xpect® First aid WORKPLACE READY® Single Dose Tamper Evident 80 Tablets • 40 Packets (2 tablets per packet) per Box †This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®. Box40
Sequence 2
Principal Display Panel - 42961-234-05 †Compare to the active ingredients of Excedrin® EXTRA STRENGTH PAIN AWAY® Active Ingredients: Acetaminophen Aspirin (NSAID) Caffeine Pain Reliever / Pain Reliever Aid Relief from headaches Contains caffeine Xpect® First aid WORKPLACE READY® Single Dose Tamper Evident 160 Tablets • 80 Packets (2 tablets per packet) per Box †This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin®. Box80
Pregnancy Or Breast Feeding (1)
Sequence 1
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.
Purpose (1)
Sequence 1
Purpose Pain reliever Pain reliever Pain reliever aid
Questions (1)
Sequence 1
Questions? 1-877-973-2811 Monday-Friday 8:00 AM-5:00 PM
Spl Product Data Elements (1)
Sequence 1
Xpect Pain Away Extra Strength Acetaminophen Aspirin Caffeine ACETAMINOPHEN ACETAMINOPHEN ASPIRIN ASPIRIN CAFFEINE CAFFEINE STARCH, CORN CROSPOVIDONE HYPROMELLOSE, UNSPECIFIED MICROCRYSTALLINE CELLULOSE POVIDONE PROPYLENE GLYCOL SODIUM LAURYL SULFATE SODIUM STARCH GLYCOLATE TYPE A STEARIC ACID TITANIUM DIOXIDE
Stop Use (1)
Sequence 1
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 • have bloody or black stools • vomit blood • have stomach pain that does not get better ringing in the ears or a loss of hearing occurs redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur These could be signs of a serious condition.
Warnings (1)
Sequence 1
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 bahavior with nausea and vomiting occur, consult a doctor becuase 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 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 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 heart beat. Do not use 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 if you have ever had an allergic reaction to this product or any of its ingredients Ask a doctor before use if you have liver disease you have asthma stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn 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 precription 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 an allergic reaction occurs. Seek medical help right away 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 ringing in the ears or a loss of hearing occurs redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days new symptoms occur 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 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 accidental 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.
OpenFDA raw payload
{'application_number': ['M013'],
'brand_name': ['Xpect Pain Away Extra Strength'],
'generic_name': ['ACETAMINOPHEN ASPIRIN CAFFEINE'],
'is_original_packager': [True],
'manufacturer_name': ['Cintas Corporation'],
'nui': ['N0000000160',
'N0000008836',
'M0001335',
'N0000175722',
'N0000175578',
'N0000008832',
'N0000175739',
'N0000175729',
'N0000175790',
'M0023046'],
'package_ndc': ['42961-234-01',
'42961-234-02',
'42961-234-04',
'42961-234-05',
'42961-234-03'],
'pharm_class_cs': ['Anti-Inflammatory Agents, Non-Steroidal [CS]',
'Xanthines [CS]'],
'pharm_class_epc': ['Nonsteroidal Anti-inflammatory Drug [EPC]',
'Platelet Aggregation Inhibitor [EPC]',
'Central Nervous System Stimulant [EPC]',
'Methylxanthine [EPC]'],
'pharm_class_moa': ['Cyclooxygenase Inhibitors [MoA]'],
'pharm_class_pe': ['Decreased Prostaglandin Production [PE]',
'Decreased Platelet Aggregation [PE]',
'Central Nervous System Stimulation [PE]'],
'product_ndc': ['42961-234'],
'product_type': ['HUMAN OTC DRUG'],
'route': ['ORAL'],
'rxcui': ['308297'],
'spl_id': ['b7379830-65bc-4257-8915-b0f14f506e93'],
'spl_set_id': ['1269d069-afaf-4ca5-b369-f74249a348db'],
'substance_name': ['ACETAMINOPHEN', 'ASPIRIN', 'CAFFEINE'],
'unii': ['362O9ITL9D', 'R16CO5Y76E', '3G6A5W338E']}