Each Women's Tylenol® Multi-Symptom Menstrual Relief Caplet contains acetaminophen 500 mg and pamabrom 25 mg.

ACTIONS

Women's TYLENOL® Multi-Symptom Menstrual Relief Caplets contain a clinically proven analgesic-antipyretic and a diuretic. Maximum allowable non-prescription levels of acetaminophen and pamabrom provide temporary relief of minor aches and pains due to cramps, headache, and backache and water retention, weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual periods. Acetaminophen is equal to aspirin in analgesic and antipyretic effectiveness and it is unlikely to produce many of the side effects associated with aspirin containing products. Acetaminophen produces analgesia by elevation of the pain threshold. Pamabrom is a diuretic which relieves water retention.

USES

Women's TYLENOL® Multi-Symptom Menstrual Relief Caplets: For the temporary relief of minor aches and pains due to cramps, headache, backache. Temporarily relieves water weight gain, bloating, swelling and full feeling associated with the premenstrual and menstrual periods.

DIRECTIONS

Do not take more than directed. Adults and children 12 years and over: Take 2 caplets every 4 to 6 hours, do not take more than 8 caplets in 24 hours, or as directed by a doctor. Children under 12 years: Do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

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. Do not use if carton is opened, or if neck wrap or foil inner seal imprinted "Safety Seal®" is broken or missing.

Do not use

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use

Keep out of reach of children.

In case of overdose, immediately 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.

PROFESSIONAL INFORMATION

OVERDOSAGE INFORMATION

Acetaminophen in massive overdosage may cause hepatic toxicity in some patients. In adults and adolescents (>/=12 years of age), hepatic toxicity may occur following ingestion of greater than 7.5 to 10 grams over a period of 8 hours or less. Fatalities are infrequent (less than 3-4% of untreated cases) and have rarely been reported with overdoses of less than 15 grams. In children (<12 years of age), an acute overdosage of less than 150 mg/kg has not been associated with hepatic toxicity. Early symptoms following a potentially hepatotoxic overdosage 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 adults and adolescents, any individual presenting with an unknown amount of acetaminophen ingested or with a questionable or unreliable history about the time of ingestion should have a plasma acetaminophen level drawn and be treated with N -acetylcysteine. For full prescribing information, refer to the N -acetylcysteine package insert. Do not await results of assays for plasma acetaminophen levels before initiating treatment with N -acetylcysteine. The following additional procedures are recommended: Promptly initiate gastric decontamination of the stomach. A plasma acetaminophen assay should be obtained as early as possible, but no sooner than four hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be continued for a full course of therapy. Liver function studies should be obtained initially and repeated at 24-hour intervals.

Serious toxicity or fatalities have been extremely infrequent following a acute acetaminophen overdose in young children, possibly because of differences in the way they metabolize acetaminophen. In children, the maximum potential amount ingested can be more easily estimated. If more than 150 mg/kg or an unknown amount ingested, obtain a plasma acetaminophen level as soon as possible, but no sooner than 4 hours following ingestion. If an acetaminophen extended release product is involved, it may be appropriate to obtain an additional plasma acetaminophen level 4-6 hours following the initial acetaminophen level. If either acetaminophen level plots above the treatment line on the acetaminophen overdose nomogram, N -acetylcysteine treatment should be initiated and continued for a full course of therapy. If an assay cannot be obtained and the estimated acetaminophen ingestion exceeds 150 mg/kg, dosing with N -acetylcysteine should be initiated and continued for a full course of therapy.

For additional emergency information, call your regional poison center or call the Rocky Mountain Poison Center toll-free, (1-800-525-6115).

Acute overexposure of diuretics is primarily associated with fluid and electrolyte loss. Fluid loss should be corrected with the appropriate intravenous and/or oral fluids.

Alcohol Information:   Chronic heavy alcohol abusers may be at increased risk of liver toxicity from excessive acetaminophen use, although reports of this event are rare. Reports usually involve cases of severe chronic alcoholics and the dosages of acetaminophen most often exceed recommended doses and often involve substantial overdose. Healthcare professionals should alert their patients who regularly consume large amounts of alcohol not to exceed recommended doses of acetaminophen.

INACTIVE INGREDIENTS

cellulose, corn starch, hydroxypropyl methylcellulose, magnesium stearate, polydextrose, polyethylene glycol, sodium starch glycolate, titanium dioxide, triacetin.

HOW SUPPLIED

Caplets--white capsule shaped caplets with TYME printed on one side in tamper-evident bottles of 24 and 40. Store at room temperature; avoid excessive heat 40 C (104 F).

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug' identity should be verified by chemical analysis.

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