PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet

Pain Relief Extra Strength by

Drug Labeling and Warnings

Pain Relief Extra Strength by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Acetaminophen 500mg

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health
professional before use.

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

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

PAIN RELIEF EXTRA STRENGTH 
acetaminophen tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-446
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
POVIDONE K29/32 (UNII: 390RMW2PEQ)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (AZ235)	Size	12mm
Flavor		Imprint Code	AZ235
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-446-02	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part343	10/15/2012

Labeler - Select Corporation (053805599)

Registrant - Select Corporation (053805599)