Otc - Active Ingredient
Active Ingredients
Acetaminophen 500mg
Pain Relief Extra Strength
FDA Label NDC 52904-446
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Select Corporation for the product Pain Relief Extra Strength (NDC 52904-446). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, dosage & administration, indications & usage, warnings, otc - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Analgesic, Antipyretic
Dosage & Administration
Directions: Adults and children
12 years of age and older: • take 2 tablets every 4 to 6 hours
as needed • do not take more than 8 tablets in 24 hours. 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.
Indications & Usage
Uses: • temporary relief of minor aches and pains associated with
• common cold • headache • backache • arthritis • toothache •
muscular aches • menstrual cramps • and reduction of fever
Warnings
Warnings:
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 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: • pain gets worse or lasts for more than 10 days • a
rare sensitivity reaction occurs • fever gets worse or lasts more
than 3 days • symptoms do not improve • new symptoms occur •
redness or swelling is present. You may report side effects to
888-952-0050.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health
professional before use.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN.
Inactive Ingredient
Inactive ingredients: corn starch, hydoxypropyl methylcellulose,
polyethylene glycol, pregelatinized starch, stearic acid, titanium
dioxide. May contain povidone and sodium starch glycolate
Package Label.Principal Display Panel
MM1
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