ANACIN ASPIRIN FREE- acetaminophen capsule 
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.

----------

ASPIRIN FREE
ANACIN®
EXTRA STRENGTH

Drug Facts

Active ingredient (per caplet)

Acetaminophen 500 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

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

Warnings

Liver warning

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

  • more than 8 caplets in 24 hours which is the maximum daily amount
  • 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.

Ask a doctor before use if you have

  • liver disease

Ask a doctor or pharmacist before use if you are taking the blood thinning drug Warfarin.

Stop use and ask a doctor if

  • new symptoms occur
  • redness or swelling is present
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose warning

In 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)
  • 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

Inactive ingredients

corn starch, 1methyl paraben, povidone, 1propyl paraben, 1sodium starch glycolate and stearic acid.

1
may contain this ingredient

Other information

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

Questions

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

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

PRINCIPAL DISPLAY PANEL - 100 Caplet Carton

Now with Easy Open Cap
ASPIRIN FREE

SEE NEW WARNINGS INFORMATION

ANACIN®
EXTRA STRENGTH
Acetaminophen 500 mg
Pain Reliever / Fever Reducer

Easy to Swallow Caplets
100 CAPLETS

Principle Display Panel - 100 Caplet Carton
ANACIN  ASPIRIN FREE
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63736-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize17mm
FlavorImprint Code 770
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63736-310-901 in 1 BOX07/09/200908/31/2017
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 FINALpart34307/09/200908/31/2017
Labeler - Insight Pharmaceuticals LLC (055665422)

Revised: 10/2011
Document Id: 5c9bfa6c-e2b8-4a39-88da-972104d07c22
Set id: 1c404d79-a063-4333-b9da-3a1c15125efc
Version: 4
Effective Time: 20111017
 
Insight Pharmaceuticals LLC