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Sedalmex

Midway Importing, Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Acetaminophen USP 500 mg
Caffeine USP 65 mg

Pain reliever

Pain reliever aid

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

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

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

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.

•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

Microcrystalline cellulose, sodium starch glycolate, stearic acid

Package Label

Sedalmex

Sedalmex

acetaminophen and caffeine TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:76095-003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
white 13 mm MEX ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:76095-003-02 2 in 1 BOX
2 NDC:76095-003-20 20 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-08-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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