SEDALMEX PAIN RELIEVER- acetaminophen and caffeine tablet 
Midway Importing, Inc

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

Package Label

SEDALMEX  PAIN RELIEVER
acetaminophen and caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76095-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScore2 pieces
ShapeROUND (Tablet) Size13mm
FlavorImprint Code MEX
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76095-003-022 in 1 BOX; Type 0: Not a Combination Product08/15/201108/08/2017
2NDC:76095-003-2020 in 1 BLISTER PACK; Type 0: Not a Combination Product08/15/201108/08/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/15/201108/08/2017
Labeler - Midway Importing, Inc (611851627)

Revised: 8/2017
 
Midway Importing, Inc