FDA Label for Pain Relief Extra Strength Easy To Swallow
View Indications, Usage & Precautions
Pain Relief Extra Strength Easy To Swallow Product Label
The following document was submitted to the FDA by the labeler of this product Allegiant Health. 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 500 mg
Purpose
Analgesic/Antipyretic
Uses
temporary relief of minor aches and pains associated with common cold headache toothache
muscular aches backache arthritis menstrual cramps and reduction of fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen 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
Do Not Use
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
Ask A Doctor Or Pharmacist Before Use If You
are taking the blood thinning drug warfarin
Stop Use And Ask A Doctor If
symptoms do not improve pain gets worse or lasts for more than 10 days ■ fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present ■ a rare
sensitivity reaction occurs You may report side effects to 1-888-952-0050
If Pregnant Or Breast-Feeding
ask a health professional before use
Keep Out Of Reach Of Children
In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.
Directions
Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.
Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
Inactive Ingredients
carnauba wax, FD&C red #40 aluminum lake, hypromellose, polyethylene glycol(PEG) 400, polyethylene glycol (PEG) 8000, povidone, pregelatinized starch, stearic acid, sucralose, titanium dioxide.
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