FDA Label for X Ray Pain Reliever
View Indications, Usage & Precautions
- OTHER
- OTC - PURPOSE
- USES
- REYE'S SYNDROME
- ALLERGY ALERT
- LIVER WARNING
- STOMACH BLEEDING WARNING
- CAFFEINE WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL - 24 TABLET BOTTLE CARTON
X Ray Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Genomma Lab Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Genomma Lab USA Inc., Houston, TX 77098
Otc - Purpose
| Active ingredients (in each tablet) | Purposes |
|---|---|
| Acetaminophen 250mg | Pain reliever |
| Aspirin 250mg (NSAID nonsteroidal anti-inflammatory drug ) | 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
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
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin reaction occurs, stop use and seek medical help right away.
Aspirin may cause a severe allergic reaction which may include:
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
Otc - Pregnancy Or Breast Feeding
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.
Otc - Keep Out Of Reach Of Children
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
Principal Display Panel - 24 Tablet Bottle Carton
Acetaminophen / Aspirin (NSAID) and Caffeine
Pain Reliever / Pain reliever aid
X RAY®
PAIN RELIEVER
✓ EXTRA STRENGTH- ARTHRITIS AND JOINT PAIN
- HEADACHE
- ACHES AND PAIN DUE TO A COLD
- MUSCULAR ACHES
- MENSTRUAL CRAMP PAIN
RELIEVES:
24 | TABLETS
* Please review the disclaimer below.