ANACIN- aspirin and caffeine capsule, coated 
Insight Pharmaceuticals LLC

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.

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ANACIN®

Drug Facts

Active ingredients (per caplet)Purposes
*
nonsteroidal anti-inflammatory drug
 Aspirin (NSAID)* 400 mg Pain reliever
 Caffeine 32 mg Pain reliever aid

Uses

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • muscular aches
  • sore throat
  • arthritis
  • toothache
  • menstrual cramps
  • backache

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

Stomach bleeding warning

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinner (anticoagulant) or steroid drug
  • take other drugs containing prescription or non prescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you have ever had an allergic reaction to any other pain reliever/fever reducer

Ask a doctor before use if

  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diaretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
    • an allergic reaction occurs. Seek medical help right away.
    • new symptoms occur
    • ringing in the ears or loss of hearing occurs
    • redness or swelling is present
    • 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

In case of overdose, get medical help or contact a Poison Control Center right away.

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 older: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours, or as directed by a doctor
  • children under 12 years of age: ask a doctor

Other information

Keep carton for full drug facts and warnings. Read all warnings and directions before use. Store at 15° – 25°C (59° – 77°F). Protect from moisture.

Inactive ingredients

hypromellose, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate, starch

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

Questions?

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

PRINCIPAL DISPLAY PANEL - 100 Caplet Carton

Do Not Use if foil seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

Pain Reliever (NSAID) + Pain Reliever Aid

• TRUSTED • SAFE
• EFFECTIVE
100

COATED
CAPLETS

SEE NEW WARNINGS INFORMATION

Principle Display Panel - 100 Caplet Carton
ANACIN 
aspirin and caffeine capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-206
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN400 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE32 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-206-901 in 1 BOX06/29/200908/31/2017
1100 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34306/29/200908/31/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 10/2011
 
Insight Pharmaceuticals LLC