X RAY PAIN RELIEVER- acetaminophen, aspirin, and caffeine tablet

X Ray Pain Reliever by

Drug Labeling and Warnings

X Ray Pain Reliever by is a Otc medication manufactured, distributed, or labeled by Genomma Lab USA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purposes
* nonsteroidal anti-inflammatory drug
Acetaminophen 250mg	Pain reliever
Aspirin 250mg (NSAID*)	Pain reliever
Caffeine 65mg	Pain reliever aid

Uses

temporarily relieves minor aches and pains due to

• headache
• a cold
• arthritis
• muscular aches
• toothache
• premenstrual and menstrual cramps

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

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 specifically 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 (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice the 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 tablets every 6 hours; not more than 8 tablets in 24 hours
• children under 12 years: ask a doctor

Other information

• store at 20°-25°C (68°-77°F)
• keep carton for full product information
• do not use if imprinted safety seal under cap is broken or missing
• you may report serious side effects to 1-888-952-0050

Inactive ingredients

corn starch, croscarmellose sodium, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, silicon dioxide, stearic acid, titanium dioxide

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 24 Tablet Bottle Carton

Acetaminophen / Aspirin (NSAID) and Caffeine
Pain Reliever / Pain reliever aid

X RAY®
PAIN RELIEVER

• ✓ EXTRA STRENGTH

RELIEVES:

• ARTHRITIS AND JOINT PAIN
• HEADACHE
• ACHES AND PAIN DUE TO A COLD
• MUSCULAR ACHES
• MENSTRUAL CRAMP PAIN

24 | TABLETS

INGREDIENTS AND APPEARANCE

X RAY PAIN RELIEVER 
acetaminophen, aspirin, and caffeine tablet

Product 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)