Anacin AF

Dosage form: tablet, coated
Ingredients: Acetaminophen 250mg, Aspirin 250mg, Caffeine 65mg
Labeler: Insight Pharmaceuticals
NDC Code: 63736-203

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.

ANACIN®
ADVANCED
HEADACHE FORMULA

Drug Facts

Active ingredients (in each tablet)

Acetaminophen 250 mg

Aspirin 250 mg

Caffeine 65 mg

Purposes

Pain reliever

Pain reliever

Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • toothache
  • muscular aches
  • arthritis
  • menstrual cramps

Warnings

Reye's syndrome

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • asthma (wheezing)
  • shock

Alcohol warning

If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen and aspirin or other pain relievers/fever reducers. Acetaminophen and aspirin may cause liver damage and stomach bleeding.

Do not use
  • if you have ever had an allergic reaction to any other pain reliever/fever reducer
  • with any other products containing acetaminophen. Taking more than directed may cause liver damage.

Ask a doctor before use if you have
  • asthma
  • ulcers
  • bleeding problems
  • stomach problems such as heartburn, upset stomach, or stomach pain that do not go away or return

Ask a doctor or pharmacist before use if you are taking a prescription drug for:

  • anticoagulation (thinning of the blood)
  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if
  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • symptoms do not get better or worsen
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

Caffeine warning

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally, rapid heart beat.

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

Overdose warning

Taking more than the recommended dose can cause serious health problems. In the case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not use more than directed (see overdose warning)
  • drink a full glass of water with each dose
  • adults and children 12 years of age and over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • read all product information before using.
  • store at 20°–25°C (68°–77°F). Protect from moisture.

Inactive ingredients

Colloidal Silicon Dioxide, Crospovidone, Lecithin, Microcrystalline Cellulose, Polyvinyl Alcohol, Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Starch, Stearic Acid, Talc, Titanium Dioxide

Distributed by: INSIGHT Pharmaceuticals Corp., Langhorne, PA 19047-1749

Questions?

Call 1-800-344-7239 or visit us at www.anacin.com

70126A

PRINCIPAL DISPLAY PANEL - 75 tablet bottle label

NEW
ANACIN®
ADVANCED
HEADACHE FORMULA

PAIN RELIEF
CONTAINS
ACETAMINOPHEN,
ASPIRIN AND
CAFFEINE

75
COATED
TABLETS

PRINCIPAL DISPLAY PANEL - 75 tablet carton

NEW
ANACIN®
ADVANCED
HEADACHE FORMULA

PAIN RELIEF
CONTAINS ACETAMINOPHEN,
ASPIRIN AND CAFFEINE

75
COATED
TABLETS

ANACIN  AF
acetaminophen, aspirin and caffeine tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-203
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Acetaminophen (Acetaminophen) Acetaminophen250 mg
Aspirin (Aspirin) Aspirin250 mg
Caffeine (Caffeine) Caffeine65 mg
Inactive Ingredients
Ingredient NameStrength
Silicon Dioxide 
Crospovidone 
Cellulose, Microcrystalline 
Polyvinyl Alcohol 
Povidone 
Starch, Corn 
Sodium Starch Glycolate Type A Potato 
Stearic Acid 
Talc 
Titanium Dioxide 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize11mm
FlavorImprint Code323
Contains    
Packaging
#Item CodePackage Description
1NDC:63736-203-751 BOTTLE (BOTTLE) in 1 BOX
175 TABLET, COATED (CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34306/29/2009
Labeler - Insight Pharmaceuticals (176792315)

Revised: 07/2009
 
Insight Pharmaceuticals

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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