Aypanal

Dosage form: tablet
Ingredients: ACETAMINOPHEN 325mg
Labeler: North Safety Products
NDC Code: 0498-2000

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.

Aypanal

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

for the temporary relief of minor aches and pains due to:

  • the common cold
  • headache
  • and to reduce fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:

  • more than 8 tablets in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Do not use

with any other drug containing acetaminophen (prescription or nonprescription)

  • if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist
  • if you have liver disease
  • you are taking the blood thinning drug Warfarin

Stop use and ask a doctor if
  • pain gets worse or lasts more than 10 days
  • fever gets worse or last more than 3 days
  • any new symptoms occur
  • redness or swelling persists, these could be signs of a serious condition

If pregnant or breast feeding

ask a health professional before use

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms

Directions

do not take more than directed

  • adults and children 12 years of age or older
  • take two tablets with water every 6 hours while symptoms persist
  • do not take more than 8 tablets in 24 hours
  • children under 12 years of age, consult a doctor

Other information
  • store at room temperature 150 to 300C  (590 - 860 F)
  • do not use if individual packet is open or torn

Inactive ingredients

corn starch, microcrystalline cellulose, povidone, sodium starch glycolate, stearic acid

Questions or comments?

1-800-430-4110

Principal display Panel

AYPANAL 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0498-2000
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A CORN  
STEARIC ACID  
Product Characteristics
Colorwhite (White) Score2 pieces
ShapeROUNDSize10mm
FlavorImprint CodeCircle;U
Contains    
Packaging
#Item CodePackage Description
1NDC:0498-2000-0626 PACKET (PACKET) in 1 BOX, UNIT-DOSE
12 TABLET (TABLET) in 1 PACKET
2NDC:0498-2000-0550 PACKET (PACKET) in 1 BOX, UNIT-DOSE
22 TABLET (TABLET) in 1 PACKET
3NDC:0498-2000-10100 PACKET (PACKET) in 1 BOX, UNIT-DOSE
32 TABLET (TABLET) in 1 PACKET
4NDC:0498-2000-25250 PACKET (PACKET) in 1 BOX, UNIT-DOSE
42 TABLET (TABLET) in 1 PACKET
5NDC:0498-2000-50500 PACKET (PACKET) in 1 BOX, UNIT-DOSE
52 TABLET (TABLET) in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/10/2012
Labeler - North Safety Products (059980441)
Establishment
NameAddressID/FEIOperations
North Safety Products059980441manufacture
Establishment
NameAddressID/FEIOperations
UltraTab Laboratories151051757manufacture

Revised: 04/2012
 
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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