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Name:Anacinaspirin Free
Manufacturer:Insight Pharmaceuticals
Category:Over-the-counter (OTC) Marketed Drugs


ASPIRIN FREEANACIN®EXTRA STRENGTH

ANACIN ASPIRIN FREE - acetaminophen capsule 
Insight Pharmaceuticals

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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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:

  • 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
  • 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). Ask a doctor or pharmacist before using with other drugs if you are not sure.

Ask a doctor before use if you have

  • liver disease

Stop use and ask a doctor if

  • new symptoms occur
  • painful area is red or swollen
  • 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 over: take 2 caplets every 6 hours; not more than 8 caplets in 24 hours, or as directed by a doctor
  • children under 12 years: 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. Read all warnings and directions before use. Store at room temperature between 20° – 25°C (68° – 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 Caplets Label

ASPIRIN FREE
ANACIN®
EXTRA STRENGTH
Acetaminophen 500 mg

Pain Reliever / Fever Reducer

100 CAPLETS

ACTIVE INGREDIENT: (per caplet) Acetaminophen 500 mg

USES: Temporarily relieves minor aches and pains due to
headache, a cold, muscular aches, arthritis, toothache
and menstrual cramps

DIRECTIONS: Do not use more than directed (see overdose
warning). Adults and children 12 years of age and over:
take 2 caplets every 6 hours; not more than 8 caplets in 24
hours, or as directed by a doctor. Children under 12 years:
ask a doctor.

Principle Display Panel - 100 Caplets Label

PRINCIPAL DISPLAY PANEL - 100 Caplets Box

Now with Easy Open Cap
ASPIRIN FREE
ANACIN®
EXTRA STRENGTH
Acetaminophen 500 mg

Pain Reliever / Fever Reducer

Easy to Swallow Caplets
100
CAPLETS

Principle Display Panel - 100 Caplets Box

ANACIN  ASPIRIN FREE
acetaminophen capsule
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-310
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 500 mg
Inactive Ingredients
Ingredient Name Strength
starch, corn  
methylparaben  
povidone  
propylparaben  
sodium starch glycolate type a potato  
stearic acid  
Product Characteristics
Color WHITE Score no score
Shape CAPSULE Size 17mm
Flavor Imprint Code 770
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-310-90 1 BOTTLE ( BOTTLE) in 1 BOX contains a BOTTLE
1 100 CAPSULE ( CAPSULE) in 1 BOTTLE This package is contained within the BOX (63736-310-90)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 07/09/2009

Labeler - Insight Pharmaceuticals (176792315)
Establishment
Name Address ID/FEI Operations
Perrigo 006013346 MANUFACTURE

Revised: 07/2009 Insight Pharmaceuticals



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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