Your browser does not support JavaScript! PAIN AID ESF (ACETAMINOPHEN, ASPIRIN, CAFFEINE) TABLET [ZEE MEDICAL INC]
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PAIN AID ESF (acetaminophen, aspirin, caffeine) tablet
[Zee Medical Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active Ingredient (in each tablet)  Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg

Purpose-Pain reliever, Fever Reducer

Uses
■ temporarily relieves pain due to:
■ headache ■ muscular aches ■ colds ■ flu
■ temporarily reduces fever

Directions
■ adults: take 2 tablets every 6 hours, not more than 8 tablets in
24 hours
■ children under 12 years: ask a doctor


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
nausea 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 ■ asthma (wheezing) ■ shock
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
Stomach bleeding warning: This product contains a
nonsteroidal anti-inflammatory drug (NSAID), which may cause
severe 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 prescription or nonprescription
NSAIDs (aspirin, 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, occasionally, rapid heart beat.
Do not use
■ if you have ever had an allergic reaction to any other pain
reliever/fever reducer
■ with any other drug containing acetaminophen (prescription
or nonprescription). If you are not sure whether a drug
contains acetaminophen, ask a doctor or pharmacist.
Stop use and ask a doctor if
■ an allergic reaction occurs. Seek medical help right away.
■ you experience any of the following signs of stomach bleeding:
■ feel faint ■ vomit blood ■ have bloody or black stools
■ have stomach pain that does not get better
■ ringing in the ears or loss of hearing occurs
■ pain gets worse or lasts more than 10 days
■ fever gets worse or lasts more than 3 days
■ redness or swelling is present in the painful area
■ any new symptoms appearAsk a doctor before use if you are taking a prescription drug for diabetes, gout, or arthritis■ stomach bleeding warning applies to you■ you have a history of stomach problems, such as heartburn you have asthma, high blood pressure, heart disease, live rdisease, or kidney disease■ you are taking a diuretic

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

KEEP OUT OF REACH OF CHILDREN. In case of overdose,  
get medical help or contact a Poison Control Center right away.  
Prompt medical attention is critical for adults as well as for  
children even if you do not notice any signs or symptoms.

Inactive ingredients cellulose*, hydroxypropyl
methylcellulose, maltodextrin*, polyethylene glycol, povidone,
propylene glycol*, sodium lauryl sulfate*, sodium starch
glycolate, starch, stearic acid, titanium dioxide
*contains one or more of these ingredients

MM1ESF 250 Box 1

PAIN AID ESF 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:35418-560
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN250 mg
ASPIRIN (ASPIRIN) ASPIRIN250 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
STARCH, CORN 
MALTODEXTRIN 
POLYETHYLENE GLYCOL 300 
POVIDONE K29/32 
SODIUM LAURYL SULFATE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TITANIUM DIOXIDE 
Product Characteristics
Colorwhite (snow white) Scoreno score
ShapeROUND (ZEE;ESF) Size12mm
FlavorImprint Code ZEE;ESF
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35418-560-6850 in 1 CARTON
1NDC:35418-560-67125 in 1 CARTON
1NDC:35418-560-7012 in 1 CARTON
1NDC:35418-560-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/12/2012
Labeler - Zee Medical Inc (009645623)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultratab Laboratories, Inc.151051757manufacture(35418-560)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004repack(35418-560)

Revised: 11/2012
 
Zee Medical Inc

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