Active Ingredients: Each tablet, caplet or geltab contains: Acetaminophen 250 mg and Diphenhydramine Citrate 38 mg
Inactive Ingredients: (Tablet and Caplet) benzoic acid, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, hydroxypropyl methylcellulose, magnesium stearate, methylparaben, mineral oil, povidone, propylene glycol, propylparaben, simethicone emulsion, sodium citrate, stearic acid, titanium dioxide. May also contain: D&C Yellow #10, FD&C Blue #1, polysorbate 20, sorbitan monolaurate.
(Geltab) benzoic acid, corn starch, D&C Red #33, edetate disodium, FD&C Blue #1, FD&C Blue #1 Lake, gelatin, glycerin, hydroxypropyl methylcellulose, magnesium stearate, methylparaben, mineral oil, polysorbate 20, pregelatinized starch, propylene glycol, propylparaben, simethicone emulsion, sorbitan monolaurate, stearic acid, titanium dioxide. May also contain: D&C Yellow #10, D&C Yellow #10 Lake.
Uses: For temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness.
Alcohol Warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.
Warnings: Keep out of reach of children. 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. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product. Do not give to children under 12 years of age or use for more than 10 days unless directed by a doctor. If symptoms persist or get worse, if new ones occur, or if sleeplessness persists continuously for more than 2 weeks, consult your doctor. Insomnia may be a symptom of serious underlying medical illness. Do not take this product, unless directed by a doctor, if you have a breathing problem such as emphysema or chronic bronchitis, or if you have glaucoma or difficulty in urination due to enlargement of the prostate gland. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedatives or tranquilizers, without first consulting your doctor.
Adults and children 12 years of age and over: 2 tablets, caplets, or geltabs at bedtime if needed or as directed by a doctor.
Overdose: Acetylcysteine As An Antidote For Acetaminophen Overdose
Acetaminophen is rapidly absorbed from the upper gastrointestinal tract with peak plasma levels occurring between 30 and 60 minutes after therapeutic doses and usually within 4 hours following an overdose. The parent compound, which is nontoxic, is extensively metabolized in the liver to form principally the sulfate and glucuronide conjugates which are also nontoxic and are rapidly excreted in the urine. A small fraction of an ingested dose is metabolized in the liver by the cytochrome P-450 mixed function oxidase enzyme system to form a reactive, potentially toxic, intermediate metabolite which preferentially conjugates with hepatic glutathione to form the nontoxic cysteine and mercapturic acid derivatives which are then excreted by the kidney. Therapeutic doses of acetaminophen do not saturate the glucuronide and sulfate conjugation pathways and do not result in the formation of sufficient reactive metabolite to deplete glutathione stores. However, following ingestion of a large overdose (150 mg/kg or greater) the glucuronide and sulfate conjugation pathways are saturated resulting in a larger fraction of the drug being metabolized via the P-450 pathway. The increased formation of reactive metabolite may deplete the hepatic stores of glutathione with subsequent binding of the metabolite to protein molecules within the hepatocyte resulting in cellular necrosis. Acetylcysteine has been shown to reduce the extent of liver injury following acetaminophen overdose. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In most adults and adolescents, regardless of the quantity of acetaminophen reported to have been ingested, administer acetylcysteine immediately. Acetylcysteine therapy should be initiated and continued for a full course of therapy. Its effectiveness depends on early administration, with benefit seen principally in patients treated within 16 hours of the overdose.
If acetaminophen plasma assay capability is not available, and the estimated acetaminophen ingestion exceeds 150 mg/kg, acetylcysteine therapy should be initiated and continued for a full course of therapy.
For full prescribing information, refer to the acetylcysteine package insert. Do not await the results of assays for acetaminophen level before initiating treatment with acetylcysteine. The following additional procedures are recommended: The stomach should be emptied promptly by lavage or by induction of emesis with syrup of ipecac. A serum acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. Liver function studies should be obtained initially and repeated at 24-hour intervals.
For additional emergency information call your regional poison center or toll-free (1-800-525-6115) to the Rocky Mountain Poison Center for assistance in diagnosis and for directions in the use of acetylcysteine as an antidote.
How Supplied: EXCEDRIN PM® is supplied as:
Light blue circular coated tablets with "PM" debossed on one side. Supplied in bottles of 10's, 24's, 50's, 100's.
Light blue coated caplet with "PM" debossed on one side. Supplied in bottles of 24's, 50's, 100's.
Gel coated-light blue and white geltabs with "PM" printed in black on one side. Supplied in bottles of 24's, 50's, 100's.
Store at room temperature.
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