Ali-Flex Tablets

Name: Ali-Flex Tablets

Ali-Flex Dye Free Tablets 100 Tablets


DOSAGE:

Adults (12 years and older) - 1/2 or 1 tablet every 4 hours.

    Maximum daily dose - 5 tablets.


Children (6 to under 12 years) - 1/2 tablet every 4 hours.

    Maximum daily dose - 2 1/2 tablets.


Children under 6 years of age consult a physician.



STORAGE:Store at room temperature. Avoid excessive heat.

PHARMACIST:Preserve and dispense in tight containers with child resistant closures.

WARNING:Keep this and all drugs out of reach of children.

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

WARNINGS: Do not take this product for pain for more than 10 days (adults) or 5 days (children) and do not take for fever for more than 3 days unless directed by a physician. If pain of fever persist, 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 sedatives or tranquilizers, without first consulting your 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 of 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:

Ali-Flex Tablets are white (dye-free) oblong scored tablets. They are debossed with ALI-FLEX on one side and scored on the other side. Supplied in bottle of 100. Rx only.

ALI-FLEX 
acetaminophen and phenyltoloxamine citrate tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55246-816
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PHENYLTOLOXAMINE CITRATE (PHENYLTOLOXAMINE) PHENYLTOLOXAMINE CITRATE 50 mg
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 500 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
MAGNESIUM STEARATE  
Product Characteristics
Color white (Dye Free) Score 2 pieces
Shape BULLET (Oblong Tablet) Size 17mm
Flavor Imprint Code AliFlex
Contains     
Packaging
# Item Code Package Description
1 NDC:55246-816-49 100 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/27/2001 07/01/2012
Labeler - Pegasus Laboratories (007124357)
Establishment
Name Address ID/FEI Operations
Pegasus Laboratories Inc 007124357 manufacture, analysis
Revised: 04/2010   Pegasus Laboratories

For the Consumer

Applies to acetaminophen / phenyltoloxamine: oral liquid, oral tablet, oral tablet extended release

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
  • Feeling confused.
  • Not able to pass urine or change in how much urine is passed.
  • Very bad dizziness or passing out.
  • Feeling very tired or weak.
  • A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Feeling sleepy.
  • Dizziness.
  • Feeling nervous and excitable.
  • Dry mouth.
  • Dry nose.
  • Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to acetaminophen / phenyltoloxamine: oral liquid, oral tablet, oral tablet extended release

Hepatic

Hepatic side effects including severe and sometimes fatal dose dependent hepatitis has been reported with the use of acetaminophen in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.[Ref]

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.[Ref]

Gastrointestinal

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.[Ref]

Gastrointestinal side effects including nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital. Gastrointestinal side effects are rare with acetaminophen use, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with the use of acetaminophen.[Ref]

Renal

Acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use as well.

A recent case control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two pills per day.[Ref]

Renal side effects have been rare with the use of acetaminophen and have included acute tubular necrosis and interstitial nephritis. Adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Hypersensitivity

Hypersensitivity side effects, including anaphylaxis and fixed drug eruptions, have been reported rarely in association with acetaminophen use.[Ref]

Hematologic

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has also been observed in the setting of acute overdose.

Hematologic side effects such as hemolytic anemia, thrombocytopenia, and agranulocytosis have been rarely caused by antihistamines.[Ref]

Dermatologic

Dermatologic side effects including erythematous skin rashes associated with acetaminophen have been reported, but are rare. Acetaminophen associated bullous erythema and purpura fulminans have also been reported.[Ref]

Respiratory

Respiratory side effects including a case of acetaminophen-induced eosinophilic pneumonia have been reported.[Ref]

Cardiovascular

Cardiovascular side effects including two cases of hypotension have been reported following the administration of acetaminophen.

Cardiovascular side effects from the use of antihistamines have included hypotension, tachycardia, and palpitations.[Ref]

Two cases hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Metabolic

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.[Ref]

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.[Ref]

Some side effects of Ali-Flex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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