Label: X RAY PAIN RELIEVER- acetaminophen, aspirin, and caffeine tablet
- NDC Code(s): 50066-455-24
- Packager: Genomma Lab USA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 22, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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
Acetaminophen may cause severe skin reactions. Symptoms may inlclude:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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:
- are 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 non prescription 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 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 a prescription drug for diabetes, gout, or arthritis
- taking any other drug, or 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 occur These could be signs of a serious condition
- Directions
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton
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INGREDIENTS AND APPEARANCE
X RAY PAIN RELIEVER
acetaminophen, aspirin, and caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50066-455 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 HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MICROCRYSTALLINE CELLULOSE 112 (UNII: X7XJ6RM9Q2) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) silicon dioxide (UNII: ETJ7Z6XBU4) stearic acid (UNII: 4ELV7Z65AP) talc (UNII: 7SEV7J4R1U) Product Characteristics Color WHITE Score no score Shape ROUND Size 11mm Flavor Imprint Code AZ;285 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50066-455-24 1 in 1 CARTON 12/22/2023 1 24 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph drug M013 12/22/2023 Labeler - Genomma Lab USA (832323534)