PAIN RELIEVER PLUS- acetaminophen, aspirin and caffeine tablet, film coated 
Clinical Solutions Wholesale

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Major 44-159

Active ingredients (in each tablets)

Acetaminophen 250 mg
Aspirin 250 mg (NSAID)*
Caffeine 65 mg

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever
Pain reliever
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:
headache
a cold
arthritis
muscular aches
sinusitis
toothache
premenstrual and menstrual cramps

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with naussea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction, which may include:

hives
facial swelling
shock
asthma (wheezing)

Liver warning: This product contains acetaminophen. Severe lliver 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

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older
hae had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs [aspiring, ibuprofen, naproxen or others]
have 3 or more alcoholic drinks every day while using this product
take more or for a longer time than directed

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and, occasionaly, rapid heartbeat.

Do not use

if you ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
with any other drug containing acetaminophen (prescription or non prescription). 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
stomach bleeding warning appies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis or kidney disease

Ask a doctor or pharmacist before use if you are

taking a prescription drug for diabetes, gout, or arthritis
taking any other drug or are under a doctor's care for any serious condition

Stop use and ask a doctor if

you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
an allergic reaction occurs. Seek medical help right away.
any new symptoms appear
ringing in the ears or loss of hearing occurs
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
painful area is red or swollen

If pregnant or breast-feeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely 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.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

do not use more than directed
drink a full glass of water with each dose
adults and children 12 years and over
take 2 tablets every 6 hours
do not take more than 8 tablets in 24 hours
children under 12 years: do not use unless directed by a doctor

Other information

store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
see end flap for expiration date and lot number

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions or comments?

(800) 616-2471

Principal Display Panel

MAJOR®

COMPARE TO the active ingredients in EXCEDRIN® Extra Strength†

PAIN RELIEVER
PLUS
Acetaminophen, Aspirin (NSAID) and caffeine
Pain Reliever / Pain Reliever Aid

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by Novartis Consumer Health, Inc., owner of the registered trademark Excederin® Extra Strength.
50844       REV0713C15912

Distributed by MAJOR PHARMACEUTICALS
31778 Enterprise Drive
Livonia, MI 48150 USA        M-17          Rev. 08/13
Re-order No. 252831

Pain
PAIN RELIEVER PLUS 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58118-5135(NDC:0904-5135)
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
CROSPOVIDONE (UNII: 68401960MK)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONES (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 13mm
Flavor Imprint Code 44;159
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58118-5135-3 30 in 1 BOTTLE, PLASTIC
2 NDC:58118-5135-6 60 in 1 BOTTLE, PLASTIC
3 NDC:58118-5135-9 90 in 1 BOTTLE, PLASTIC
4 NDC:58118-5135-8 30 in 1 BLISTER PACK
5 NDC:58118-5135-0 1 in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 11/17/1992
Labeler - Clinical Solutions Wholesale (078710347)
Registrant - Clinical Solutions Wholesale (078710347)
Establishment
Name Address ID/FEI Business Operations
Clinical Solutions Wholesale 078710347 REPACK(58118-5135) , RELABEL(58118-5135)

Revised: 7/2014
Document Id: 17079b90-ccb2-4f35-8641-fdf3613d834f
Set id: 17079b90-ccb2-4f35-8641-fdf3613d834f
Version: 1
Effective Time: 20140701
 
Clinical Solutions Wholesale