Label: XPECT PAIN AWAY- pain reliever tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 42961-202-01, 42961-202-02 - Packager: Cintas Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated March 31, 2021
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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
• asthma (wheezing)
• shock
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
• 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 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.
Ask a doctor before use 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 are taking a diuretic
• you have asthma
Ask a doctor or pharmacist before use if you are taking:
• any other drug containing an NSAID (prescription or nonprescription)
• a blood thinning (anticoagulant) or steroid drug
• a prescription drug for diabetes, gout, or arthritis
• 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 • vomit blood • have bloody or black stools
• have stomach pain that does not get better • ringing in the ears or loss of hearing occurs
• painful area is red or swollen • pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days • any new symptoms appear
If pregnant or breast-feeding, ask a health professional before use. It is especially important to not 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 overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. - INDICATIONS & USAGE
- KEEP OUT OF REACH OF CHILDREN
- Purposes
- Directions
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- Other Information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XPECT PAIN AWAY
pain reliever tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-202 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 Inactive Ingredients Ingredient Name Strength HYDROXYPROPYL METHACRYLATE (UNII: UKW89XAX2X) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL 250 (UNII: 5246R0812J) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape ROUND Size 11mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-202-02 100 in 1 BOX 02/27/2021 1 NDC:42961-202-01 2 in 1 PACKET; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA075794 02/27/2021 Labeler - Cintas Corporation (056481716) Registrant - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations UltraTab Laboratories 151051757 manufacture(42961-202)