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  5. Label Information: Pain Relief Extra Strength

FDA Label for Pain Relief Extra Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. DOSAGE & ADMINISTRATION
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. INACTIVE INGREDIENT
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Relief Extra Strength Product Label

The following document was submitted to the FDA by the labeler of this product Select Corporation. 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.

Otc - Active Ingredient



Active Ingredients

Acetaminophen 500mg

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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