OTC Medication Information: Anacin Aspirin Free

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.

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
(click image for full-size original)
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 LLC (176792315)
Establishment
Name Address ID/FEI Operations
Perrigo 006013346 MANUFACTURE

Revised: 10/2011 Insight Pharmaceuticals LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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