Be-Flex Plus

Generic Name: acetaminophen, salicylamide, and phenyltoloxamine citrate
Dosage Form: capsule, gelatin coated

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.

Be-Flex Plus

Be-Flex Plus Description

Each Be-Flex Plus Capsule contains:

Acetaminophen ……………... 300 mg

Salicylamide ....................... 200 mg

Phenyltoloxamine Citrate .... 20 mg

Acetaminophen, 4’hydroxyacetanilide, a slightly bitter, white, odorless, crystalline powder is a non-opiate, nonsalicylate analgesic and antipyretic. It is soluble in boiling water and in 1 N sodium hydroxide; freely soluble in alcohol. It has the following structural formula:

C8H9NO2                 M.W. 151.16

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Salicylamide, 2-hydroxybenzamide, is an analgesic which occurs as a white, practically odorless, crystalline powder. It is slightly soluble in water and in chloroform; soluble in alcohol and in propylene glycol; freely soluble in ether and in solutions of alkalies. It has the following structural formula:

C7H7NO2                          M.W. 137.14

Phenyltoloxamine citrate, N, N-dimethyl-2-(α-phenyl-o-tolyloxy)-ethylamine citrate, is an antihistamine which occurs as crystals from water or methanol. It is soluble in water. Phenyltoloxamine has the following structural formula:

C17H21NO • C6H8O7                    M.W. 447.36

INACTIVE INGREDIENT

Be-Flex Plus Capsules contain the following inactive ingredients: Croscarmellose Sodium, FD&C Blue #1 Lake, FD&C Red #40 Lake, Gelatin, Polyvinylpyrrolidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid and Titanium Dioxide.

Be-Flex Plus - Clinical Pharmacology

Be-Flex Plus is designed to combine the analgesic, antipyretic properties of acetaminophen and salicylamide with mild antihistamine properties of phenyltoloxamine. Salicylamide is the amide of salicylic acid but it is not metabolized to salicylate and does not show cross sensitivity reactions with salicylate compounds. Consequently, it may be administered to patients hypersensitive to aspirin and other salicylates. In addition to analgesic action, salicylamide is also categorized as an antipyretic and antirheumatic agent.

Salicylamide is rapidly and almost completely absorbed from the GI tract following oral administration and therefore promotes an initial, rapid relief from pain or fever. It has not been established whether salicylamide has anti-inflammatory effects. In animals the drug produces hypotensive effects, possibly by dilating peripheral blood vessels, and depresses the CNS.

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 systems; however, toxic doses may cause circulatory failure and rapid, shallow breathing. Acetaminophen is rapidly and completely absorbed from the gastrointestinal tract and is distributed throughout most body tissues. 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.

Phenyltoloxamine belongs to the ethanolamine chemical class of antihistamines. It acts by competing with histamine for H1 histamine receptor sites, thereby preventing the action of histamine on the cell. Clinically, phenyltoloxamine suppresses the histamine mediated symptoms of allergic rhinitis, relieving sneezing, rhinorrhea, and itching of the eyes, nose, and throat.

Indications and Usage for Be-Flex Plus

Be-Flex Plus Capsules are indicated for the temporary relief of mild to moderate pain and discomfort due to simple headache; for temporary relief of such pain associated with muscle and joint soreness, neuralgia, sinusitis, minor menstrual cramps, the common cold or grippe, toothache, and minor aches and pains of rheumatism and arthritis.

Contraindications

Be-Flex Plus Capsules are contraindicated in patients hypersensitive to acetaminophen, salicylates, or phenyltoloxamine. Be- Flex Plus Capsules should not be taken by patients taking medication for blood-clotting or if they have kidney or liver dysfunction.

Warnings

Caution: If pain persists for more than 10 days, or if redness is present, consult a physician immediately. Children and teenagers should not use this medication for chicken pox or flu symptoms before a doctor is consulted about Reye syndrome, a rare but serious illness. Acetaminophen in massive overdosage may cause hepatotoxicity in some patients (see OVERDOSAGE). Salicylates should be used with extreme caution in the presence of peptic ulcer or coagulation abnormalities. In rare instances, the use of salicylamide in persons allergic to salicylates can result in life-threatening allergic episodes. Phenyltoloxamine citrate should be used with extreme caution in patients with stenosing peptic ulcer, pyloroduodenal obstruction, prostatic hypertrophy, or bladder neck obstruction. This compound has an atropine-like action and therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, cardiovascular disease, or hypertension.

Precautions

General

Patients who have bronchial asthma or are allergic to aspirin, use with caution until sensitivity has been determined.

Information for Patients

This product may cause sedation. Patients should be cautioned against engaging in activities requiring mental alertness, such as driving a car or operating machinery.

Drug Interactions

The sedative effects of phenyltoloxamine are additive to the CNS depressant effects of alcohol, hypnotics, sedatives and tranquilizers. Although it has not been established that salicylamide shares all the toxic potentials of salicylates, the usual precautions of salicylate administration should probably be observed since salicylamide is structurally and pharmacologically related to the salicylates. Be-Flex Plus Capsules may increase the effects of oral anticoagulants and this may result in abnormal bleeding. Phenobarbital may decrease the effect of acetaminophen by hastening its elimination from the body.

DRUG & OR LABORATORY TEST INTERACTIONS

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Be-Flex Plus Capsules. It is also not known whether Be-Flex Plus Capsules can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Be-Flex Plus Capsules should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Acetaminophen is known to be excreted in human milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness of Be-Flex Plus Capsules in children below the age of 6 have not been established.

Geriatric Use

Do not exceed a total dose of 8 capsules in 24 hours. This drug may be eliminated more slowly than in younger adults. Prolonged use in excessive doses can cause anemia, liver damage with jaundice, and kidney damage.

Adverse Reactions

The following adverse reactions have been reported for each of the individual components or combinations of ingredients.

Acetaminophen - urticaria, epigastric distress, dizziness, palpitations, allergic reactions, rash, thrombocytopenia, and agranulocytosis.

Salicylamide - Dose-related GI and CNS disturbances are the most common adverse effects of salicylamide. GI disturbances may include nausea, vomiting, heartburn, anorexia, or diarrhea. CNS disturbances may include dizziness, drowsiness, lightheadedness, faintness, or headache. Flushing, hyperventilation, sweating, dry mouth, rash, thrombocytopenia purpura, and mild salicylism have also been reported. Adverse GI and CNS effects occur infrequently with salicylamide doses of 325-650 mg but occur often with higher doses. Tinnitus, ecchymoses, hemorrhagic lesions, leukopenia, or thrombocytopenia may also occur with high doses.

Phenyltoloxamine - urticaria, drowsiness, disturbed coordination, inability to concentrate, dizziness, insomnia, tremors, nervousness, palpitation, convulsions, muscular weakness, gastric distress, diarrhea, intestinal cramps, blurred vision, hypotension, urinary retention, dryness of mouth, throat and nose, xerostomia and nausea.

Overdosage

Acetaminophen:

Signs and Symptoms: 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, diaphoresis and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours postingestion. In adults hepatic toxicity has rarely been reported with acute overdoses of less than 10 grams, or fatalities with less than 15 grams.

Treatment: The stomach should be emptied promptly by gastric lavage or by induction of emesis with syrup. 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 enzymes 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 10 g.

Salicylamide:

Signs and Symptoms: Mild salicylate toxicity may produce symptoms of dizziness, tinnitus, difficulty in hearing, nausea, vomiting, diarrhea and mental confusion.

Treatment: These symptoms will usually disappear after the medication is discontinued and blood levels of the salicylate drops.

Be-Flex Plus Dosage and Administration

Adults and children 12 years and older: 1 or 2 capsules every 4 hours; maximum daily dose, 8 capsules. Children 6 to 12 years of age: one-half adult dose; maximum daily dose, 4 capsules.
Do not use for more than 10 days unless directed by physician.

How is Be-Flex Plus Supplied

Be-Flex Plus Capsules contain acetaminophen 300 mg, salicylamide 200 mg, and phenyltoloxamine citrate 20 mg, and are supplied as orange colored capsules imprinted “LL 16” on capsule body, in bottles of 100, NDC 68047-116-01.

Storage and Handling

Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light resistant container as defined in USP/NF with a child-resistant closure.

WARNING: KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

CAUTION: Federal law prohibits dispensing without a prescription.

Rx Only

Manufactured for:

Larken Laboratories, Inc.
Canton, MS 39110
www.larkenlabs.com

Comments or Questions: 888-527-5522

Manufactured by:

Contract Pharmacal Corp.
Hauppauge, NY 11788

ISS. 05/08

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Figure 1: Container Label

BE-FLEX  PLUS
acetaminophen, salicylamide, and phenyltoloxamine citrate capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68047-116
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 300 mg
SALICYLAMIDE (SALICYLAMIDE) SALICYLAMIDE 200 mg
PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE 20 mg
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM  
FD&C BLUE NO. 1  
FD&C RED NO. 40  
GELATIN  
CROSPOVIDONE  
STARCH, CORN  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
TITANIUM DIOXIDE  
Product Characteristics
Color ORANGE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code LL16
Contains         
Packaging
# Item Code Package Description
1 NDC:68047-116-01 100 CAPSULE, GELATIN COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 04/17/2006
Labeler - Larken Laboratories Inc. (791043719)
Registrant - Larken Laboratories, Inc. (791043719)
Establishment
Name Address ID/FEI Operations
Contract Pharmacal Corp. 057795122 MANUFACTURE
Revised: 02/2010
 
Larken Laboratories Inc.

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