SEDALMEX (acetaminophen 500 mg caffeine 65 mg) Dailymed
Generic: acetaminophen, caffeine is used for the treatment of Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Apnea Fatigue
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Active Ingredients (in Each Gelcap)
Acetaminophen 500 mg(formulated with 65 mg caffeine)
Purpose
Pain reliever
Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert:Â Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- bulers
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen
Ask a doctor before use if you have
liver disease.
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.
Stop use and ask a doctor if
- new symptoms occur
- painful area is red or swollen
- pain gets worse or lasts for more than 10 days
- fever gets worse or lasts for more than 3 days
These could be signs of a serious condition.
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
In case of accidental 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
- adults and children 12 years and over: take 2 gelcaps every 6 hours. Do not take more than 6 gelcaps in 24 hours.
- children under 12 years: ask a doctor
Other Information
- store at 25ÂșC (77ÂșF); excursions permitted between 15Âș-30ÂșC (59Âș-86ÂșF)
- avoid high humidity
- see end flap for expiration date and lot number
Inactive Ingredients
corn starch, FD&C blue #1, FD&C red #40, gelatin, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, propylene glycol, shellac glaze, silicon dioxide, simethicone, sodium starch glycolate, stearic acid, titanium dioxide
Questions Or Comments?
Call 1-888-779-2877 M-F 9AM-5PM EST
Principal Display Panel
NDC 27854-301-01
SEDALMEX
RAPID RELEASE
Temporary relief of minor aches & pains.
Acetaminophen & Caffeine Pain Reliever
24 GELCAPS
Actual Size
ACETAMINOPHEN 500 mg, CAFFEINE 65 mg
ASPIRIN FREE
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
Distributed by: Belmora LLC3033 Wilson Blvd. Suite 700Arlington, VA 22201www.sedalmexusa.com
REV1119B57208
ÂSedalmex B-0099-572-08 REV1119B
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"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
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