PAIN RELIEF MAXIMUM STRENGTH- acetaminophen,aspirin,caffeine tablet, coated

Pain Relief Maximum Strength by

Drug Labeling and Warnings

Pain Relief Maximum 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 250 mg
Aspirin 250 mg
Caffeine 65 mg

PURPOSE

Pain Reliever, Fever Reducer

DOSAGE & ADMINISTRATION

Directions: Adults and children 12 years of age and older: 2 tablets as
needed for pain every 6 hours. Do not exceed 8 tablets in 24 hours or as
directed by a doctor. Children under 12 years: Consult a doctor

INDICATIONS & USAGE

Uses: temporarily relieves minor aches and pains associated with:
backache headaches colds toothache minor arthritis pain
muscular aches

WARNINGS

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. Allergy
Alert-Do not use: if you are allergic to aspirin or any other salicylate
If you have ever had an allergic reaction to any other pain
reliever/fever reducer Liver Warning: This product contains
acetaminophen. Severe liver damage may occur if you take: more
than 8 tablets in 24 hours with other drugs containing acetaminophen
(prescription or nonprescription). Ask a doctor or pharmacist before
using with other drugs if you are not sure. 3 or more alcoholic drinks
every day while using this product Stomach Bleeding Warning: This
product contains nonsteroidal antiinflammatory dugs (NSAIDs), which
may cause stomach bleeding. The chance is higher if you: are age 60
or older have had stomach ulcers or bleeding problems take a blood
thinning (anticoagulant) or steroid drug take other drugs containing an
NSAID (aspirin, ibuprofen, naproxen, or others). 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. When using this product do not exceed recommended dose.
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

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding 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

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

IInactive Ingredients: Hydroxypropyl Methylcellulose, Maltodextrin,
Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Sodium Starch
Glycolate, Starch, Stearic Acid, Titanium Dioxide

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

PAIN RELIEF MAXIMUM STRENGTH  
acetaminophen,aspirin,caffeine tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-468
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE K29/32 (UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (snow white)	Score	no score
Shape	ROUND (FR9)	Size	12mm
Flavor		Imprint Code	FR9
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-468-02	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)