Ali-Flex Tablets

Generic Name: phenyltoloxamine citrate and acetaminophen
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.

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



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