Label: XPECT PAIN AWAY EXTRA STRENGTH- acetaminophen aspirin caffeine tablet
- NDC Code(s): 42961-234-01, 42961-234-02, 42961-234-03
- Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated July 26, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
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.
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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Principal Display Panel - 42961-234-02
†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
100 Tablets • 50 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®.
111689
-
Principal Display Panel - 42961-234-03
†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
250 Tablets • 125 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®.
111699
-
INGREDIENTS AND APPEARANCE
XPECT PAIN AWAY EXTRA STRENGTH
acetaminophen aspirin caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-234 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) CROSPOVIDONE (UNII: 2S7830E561) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM LAURYL SULFATE (UNII: 368GB5141J) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape OVAL Size 15mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-234-02 50 in 1 BOX 07/26/2023 1 NDC:42961-234-01 2 in 1 PACKAGE; Type 0: Not a Combination Product 2 NDC:42961-234-03 125 in 1 BOX 07/26/2023 2 NDC:42961-234-01 2 in 1 PACKAGE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 07/26/2023 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations L.N.K. International Inc. 832867894 manufacture(42961-234)