Your browser does not support JavaScript! SEDALMEX PAIN RELIEVER (ACETAMINOPHEN AND CAFFEINE) TABLET [MIDWAY IMPORTING, INC]
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SEDALMEX PAIN RELIEVER (acetaminophen and caffeine) tablet
[Midway Importing, 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 Ingredients (in each tablet)
Acetaminophen USP 500 mg
Caffeine USP 65 mg

Purpose
Pain reliever
Pain reliever aid

Uses temporarily relieves minor aches and pains due to: •Headache,  •a cold •backache •toothache •muscular aches •arthritis

Warning: Do not use •More than recommended dosage  •For pain for more than 3 days with any other product containing Acetaminophen

Liver warning  This product contains acetaminophen. Severe liver damage may occur if you take   •more than 8 caplets 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

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.

Stop use and ask a doctor if •Pain gets worse or lasts more than 10 days •Fever gets worse or lasts more than 3 days •New symptoms occur •Redness or swelling is present •Symptoms do not get better.These could be signs of a serious condition

Pregnant or breast-feeding, ask a health professional before use. Keep out the reach of children


Overdose Warning Taking more than the recommended dose (overdoes) may cause liver damage. 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.


Directions •Do not take other than as directed •Adults and children 12 years and over, take 2 tablets every 6 hours with water as needed •Do not take more than 8 tablets in 24 hours •For children under 12 years consult a doctor.

Inactive ingredients Microcrystalline cellulose, sodium starch glycolate, stearic acid

Package Label
image of package label

SEDALMEX  PAIN RELIEVER
acetaminophen and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76095-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
CAFFEINE (CAFFEINE) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (Tablet) Size13mm
FlavorImprint Code MEX
Contains    
Packaging
#Item CodePackage Description
1NDC:76095-003-022 in 1 BOX
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/15/2011
Labeler - Midway Importing, Inc (611851627)
Establishment
NameAddressID/FEIBusiness Operations
Merck S.A. de C.V.810006213manufacture

Revised: 07/2011
Document Id: 0080cd18-b39d-4937-a8c0-545968240f5b
Set id: 6c11ac40-b302-4be9-a305-0cdd7a009c5b
Version: 1
Effective Time: 20110729
 
Midway Importing, Inc

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