FDA Label for Extra Strength Pain Reliever
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- USES:
- WARNINGS: REYE’S SYNDROME:
- LIVER WARNING:
- STOMACH BLEEDING WARNING:
- DO NOT USE:
- ASK DOCTOR BEFORE USING IF YOU HAVE:
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING A BABY,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS:
- OTHER INFORMATION:
- INACTIVE INGREDIENTS:
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Extra Strength Pain Reliever Product Label
The following document was submitted to the FDA by the labeler of this product Redicare Llc. 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.
Active Ingredient
Acetaminophen 110 mg .....................................................................................pain reliever/fever reducer
Aspirin 162 mg .....................................................................................................pain reliever/fever reducer
Caffeine 32.4 mg...............................................................................................................................adjuvant
Salicylamide 152 mg............................................................................................pain reliever/fever reducer
Uses:
temporarily relieves minor aches and pains associated with ■ headaches ■ colds ■ a toothache ■ minor arthritis pain ■ muscular aches ■ menstrual cramps ■ a backache
Warnings: Reye’S Syndrome:
Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye’s syndrome, a rare but serious illness reported to be associated with aspirin.
Liver Warning:
This product contains Acetaminophen. Severe liver damage may occur if: ■ you take more than 8 tablets in 24 hours ■ you take with other drugs containing acetaminophen (prescription or non-prescription) ■ you have 3 or more alcoholic drinks every day while using this product.
Stomach Bleeding Warning:
This product contains a non-steroidal anti-inflammatory drug (NSAIDs), which may cause stomach bleeding. The chance is higher if you ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ are age 60 or older ■ have 3 or more alcoholic drinks every day while using this product ■ take with other drugs containing a NSAID ■ you take more or for a longer time than directed.
Do Not Use:
■ if you are allergic to aspirin ■ with any other pain reliever/fever reducer ■ if you have ever had an allergic reaction to any other pain reliever/fever reducer ■ for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor ■ with any other product containing acetaminophen
Ask Doctor Before Using If You Have:
■ asthma ■ stomach problems (such as heartburn, upset stomach or stomach pain) ■ gastric ulcers ■ bleeding problems
Ask A Doctor Or Pharmacist Before Use If
you are taking a prescription drug for ■ anticoagulation (thinning of blood) ■ diabetes ■ gout ■ arthritis
Stop Use And Ask A Doctor If
■ ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse ■ new symptoms occur ■ redness or swelling is present
If Pregnant Or Breast-Feeding A Baby,
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 a case of overdose, get medical help or contact a Poison Control Center right away.
Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions:
Adults and children 12 years of age and older: Take 2 tablets every 4 hours as needed, with a full glass of water. Do not exceed 6 tablets in any 24 hour period
Children under 12 years: Ask a doctor
Other Information:
■ Tamper Evident. Do not use if packet is torn, cut or opened ■ Store at controlled room temperature 15˚ to 30˚C (59˚ to 86˚F) ■ Avoid excessive heat and humidity
Inactive Ingredients:
FD&C Yellow #6, magnesium stearate, microcrystalline cellulose, povidone, silicon dioxide, sodium starch glycolate, starch and stearic acid
* Please review the disclaimer below.