EXAPRIN- acetaminophen, aspirin, caffeine and salicylamide tablet 
HART Health

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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EXAPRIN

Active Ingredients (in each tablet):

Acetaminophen 110mg

Aspirin (NSAID)* 162mg (*nonsteroidal anti-inflammatory drug)

Caffeine 32.4mg

Salicylamide (NSAID)* 152mg (*nonsteroidal anti-inflammatory drug)

Purpose:

Pain Reliever / Fever Reducer

Pain Reliever / Fever Reducer

Pain Reliever Aid

Pain Reliever / Fever Reducer

Uses:

Temporarily relieves minor aches and pains due to

Temporarily reduces fever

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: Aspirin may cause a severe allergic reaction which may include hives, facial swelling, asthma (wheezing), or shock

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

Stomach bleeding warning:

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

Do not use

Ask a doctor before use if

Ask a doctor or pharmacist before use if you

Stop use and ask a doctor if

These could be signs of a serious condition

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 is may cause problems in the unborn child or complications during delivery

Keep out of reach of children

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In cas eof overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222

Directions: do not take more than directed.

Adults and children 12 years of age and over:

Children under 12 years of age: do not use; this will provide more than the recommended dose (overdose) and my cause liver damage

Inactive Ingredients: Corn Starch, FD&C Yellow #6 Lake, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Stearic Acid

Exaprin.jpg

EXAPRIN 
acetaminophen, aspirin, caffeine, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50332-0105
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN110 mg
ASPIRIN (ASPIRIN) ASPIRIN162 mg
CAFFEINE (CAFFEINE) CAFFEINE32.4 mg
SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE152 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
FD&C YELLOW NO. 6 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POVIDONE 
STEARIC ACID 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize12mm
FlavorImprint Code EXA
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50332-0105-320 in 1 BOX, UNIT-DOSE
12 in 1 PACKET
2NDC:50332-0105-450 in 1 BOX, UNIT-DOSE
22 in 1 PACKET
3NDC:50332-0105-7125 in 1 BOX, UNIT-DOSE
32 in 1 PACKET
4NDC:50332-0105-8250 in 1 BOX, UNIT-DOSE
42 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/20/1987
Labeler - HART Health (069560969)

Revised: 11/2012
Document Id: 16b4d71a-fead-491a-b5dc-a170f5c96dd8
Set id: 9fe82229-cc3e-4d79-a448-014fe3d0055b
Version: 1
Effective Time: 20121112
 
HART Health