Flextra 650

Generic Name: acetaminophen and phenyltoloxamine citrate
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

DESCRIPTION
Each Tablet Contains:

Acetaminophen .......... 650 mg

Phenyltoloxamine
Citrate            ............. 60 mg


Acetaminophen, 4'-hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula:

1.Acetaminophen


C8H2NO2            MW = 151.17



Phenyltoloxamine Citrate is a antihistamine having the chemical name N,N-dimethyl -2- (alpha-phenyl-o-tolyoxy) ethylamine dihydrogen citrate with the following chemical structure.

2. Phenyltoloxamine Citrate


N, N-dimethyl-2 (alpha phenyl-ortho-tolxy)-ethyl-amine citrate
C17H21NO - C5H8O7            MW = 447.48

Inactive Ingredients
Each tablet contains microcrystaline cellulose, sodium starch glycolate, and magnesium stearate. Contains FD and C Red No. 40 Aluminum Lake and Orange Lake Blend


CLINICAL PHARMACOLOGY:

The analgesic action of Acetaminophen involves peripheral influences, but the specific mechanism is as yet undetermined. Antipyretic activity is mediated through hypothalamic heat regulating centers. Acetaminophen inhibits prostaglandin synthetase. Therapeutic doses of Acetaminophen have negligible effects on the cardiovascular or respiratory system; however, toxic doses may cause circulatory failure and rapid shallow breathing.

PHARMACOKINETICS:

The behavior of the individual components is described below.

Acetaminophen:
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissue. The plasma half life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of Acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. (See Overdosage for toxicity information)

Phenyltoloxamine Citrate:
Phenyltoloxamine Citrate is an H1 blocking agent which interferes with the action of histamine primarily in capillaries surrounding mucous tissues and sensory nerves of the nasal and adjacent areas. It has the ability to interfere with certain areas of acetylcholine inhibiting secretions in the nose, mouth and pharynx. It commonly causes CNS depression.

INDICATIONS AND USAGE:

For the temporary relief of minor aches and pains associated with headaches, backache, muscular aches, the menstrual and premenstrual periods, colds, the flu, toothaches, as well as for minor pain from arthritis and to reduce fever.

CONTRAINDICATIONS:

This product should not be administered to patients who have previously exhibited hypersensitivity to Acetaminophen or Phenyltoloxamine Citrate.

Laboratory Test:

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug/Laboratory Test Interactions:

Acetaminophen may product false positive test results for urinary 5-hydroxyindoleacetic acid. The sedative effects of Phenyltoloxamine Citrate are additive to the CNS depressant effects of alcohol, hypnotics, sedative and tranquilizers.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No adequate studies have been conducted in animals to determine whether Phenyltoloxamine Citrate or Acetaminophen have a potential for carcinogenesis, mutagenesis, or impairment of fertility.

Pregnancy:

Teratogenic Effects: Pregnancy Category C: There are no adequate and well controlled studies in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Acetaminophen is excreted in breast milk in small amounts but the significance of its effect on nursing infants in not knows. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Phenyltoloxamine Citrate and Acetaminophen, a decision should be made whether to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in the pediatric population have not been established.

Germatological:skin rash and puritus.

The following adverse drug events may be borne in mind as potential effects of Acetaminophen: allergic reactions, rash, thrombocytopenia , argranulocytosis.

Overdosage:

Following an acute overdosage, toxicity may result from Phenyltoloxamine Citrate or Acetaminophen.

Acetaminophen:In Acetaminophen overdosage: dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia may also occur. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, daiphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. In adults, hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams or fatalities with less than 15 grams.

Treatment: A single or multiple overdose with Phenyltoloxamine Citrate or Acetaminophen is a potentially lethal overdose, and consultation with a regional poison control center is recommended.

Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Vomiting should be induced mechanically, or with syrup of Ipecac, if the patient is alert (adequate pharyngeal and laryngeal reflexes).

If the dose of Acetaminophen may have exceeded 140 mg/kg, acetylcysteine should be administered as early as possible. Serum Acetaminophen levels should be obtained, since levels four or more hours following ingestion help predict Acetaminophen toxicity. Do not await Acetaminophen assay results before initiating treatment. Hepatic eznymes should be obtained initially, and repeated at 24 hour intervals. Methemoglobinemia over 30% should be treated with methylene blue by slow intravenous administration. The toxic dose for adults for Acetaminophen is 10g.

Dosage:

Adults (12 years and over) - 1/2 or 1 tablet every 6 hours. Maximum daily dose - 4 tablets.

Children ( 6 to under 12 years) - 1/2 tablet every 6 hours. Maximum daily dose - 2 tablets.

Children under six years of age: Consult a physician.

Warnings:

Do not take this product for pain for more than 10 days (adults) or 5 days (children) unless directed by a physician, and do not take for fever for more than 3 days unless directed by a physician. If pain of fever persists, if new symptoms occur, or if redness or swelling is present, consult a physician immediately because these could be signs of a serious condition. Do not give this product to children under 12 years of age for the pain of arthritis unless directed by a physician. May cause drowsiness: alcohol,  sedatives and tranquilizers may increase the drowsiness effect. Avoid alcoholic beverages while taking this product. Do not take this product if you are taking sedative, or tranquilizers, without first consulting a physician. Use caution when driving a motor vehicle or operating machinery.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN

In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately. 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 advise of a health professional before using this product.

How Supplied:Flextra 650 is available as a redish orange tablet scored with POLY 650 on one side and FLEXTRA-650 on the other side. FLEXTRA-650 is packaged in bottles of 100 tablets. (NDC 50991-650-01)

STORE AT ROOM TEMPERATURE 15° - 30°C (59° - 86°F). AVOID EXCESSIVE HEAT.

FLEXTRA-650 
acetaminophen and phenyltoloxamine citrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55246-650
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 650 mg
PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE 60 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
MAGNESIUM STEARATE  
FD&C RED NO. 40  
Product Characteristics
Color red, orange Score score with uneven pieces
Shape BULLET (oblong tablet) Size 19mm
Flavor Imprint Code POLY650;FLEXTRA
Contains         
Packaging
# Item Code Package Description
1 NDC:55246-650-01 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 09/08/2006 11/30/2011
Labeler - Pegasus Laboratories (007124357)
Establishment
Name Address ID/FEI Operations
Pegasus Laboratories Inc 007124357 analysis, manufacture
Revised: 04/2001
 
Pegasus Laboratories



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