Swift Aypanal Extra

Dosage form: tablet
Ingredients: ACETAMINOPHEN 500mg
Labeler: North Safety Products
NDC Code: 0498-2100

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

In each tablet: Acetaminophen 500 mg

Purpose: Pain reliever/Fever Reducer

For the temporary relief of aches and pains due to: the common cold, headache, and to reduce fever

Liver Warning: This product contains acetaminophen

Severe liver damage may occur if: you take: this with other products containing acetaminophen,Ask a doctor or pharmacist before using other drugs if you are not sure. 3 or more alcoholic drinks every day while using this product

Do Not Use: with any other product containing acetaminophen this will provide more  
than the recommended dose (overdose) of acetaminophen and could
cause serious health concerns
For more than 10 days unless directed by a doctor
For more than 3 days for fever unless directed by a doctor
When using this prodcut do not exceed the recommended dose

Stop use and ask a doctor if: symptoms do not improve, pain or fever persists or gets worse, new symptoms ocur, redness or swelling is present


If pregnant or breast feeding a baby, ask a health professional before using this product

keep out of the reach of children.  In case of overdose, 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.

Inactive Ingredients: Microcrystalline Cellulose, Povidone, sodium starch glycolate, starch, stearic acid

MM1

Adults and Children 12 years of age and over: Take 2 tablets with water every 6 hours while symptoms persist.  Do not take any more than 8 tablets in 24 hours. Children under 12: consult a doctor

SWIFT AYPANAL EXTRA 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2100(NDC:62959-210)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
POVIDONE 
STEARIC ACID 
CELLULOSE, MICROCRYSTALLINE 
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUND (FR1) Size12mm
FlavorImprint CodeFR1
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-2100-50500 BOX (PACKET) in 1 BOX
1NDC:0498-2100-25250 BOX (PACKET) in 1 BOX
1NDC:0498-2100-10100 PACKET (PACKET) in 1 BOX
1NDC:0498-2100-012 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/14/2011
Labeler - North Safety Products (059980441)
Registrant - North Safety Products (059980441)
Establishment
NameAddressID/FEIOperations
ULTRAtab Laboratories, Inc.151051757manufacture
Establishment
NameAddressID/FEIOperations
Ultra Seal Corporation085752004repack

Revised: 04/2011
 
North Safety Products

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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