Sedalmex Pain Reliever

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg, CAFFEINE 65mg
Labeler: Midway Importing, Inc
NDC Code: 76095-003

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.

Drug Facts

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 • if you are allergic to acetaminophen •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  

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

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

If pregnant or breast-feeding,

ask a health professional before use. Keep out the reach of children

Overdose warning

Taking more than the recommended dose (overdose) 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 more than directed (see overdose warning) •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 •do not take more than 10 days unless directed by a doctor •children under 12 years of age do not use this adult extra strength product, this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

Inactive Ingredients

Microcrystalline cellulose, sodium starch glycolate, stearic acid

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 CodeMEX
Contains    
Packaging
#Item CodePackage Description
1NDC:76095-003-022 TABLET in 1 BOX
2NDC:76095-003-2020 TABLET in 1 BLISTER PACK
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/FEIOperations
Merck S.A. de C.V.810006213manufacture(76095-003)

Revised: 08/2013
 
Midway Importing, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web1)