OTC Medication Information: Anacin

ANACIN- aspirin and caffeine tablet
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.

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN ®

Drug Facts

Active ingredients (per tablet)

Aspirin (NSAID)* 400 mg
Caffeine 32 mg

* nonsteroidal anti- inflammatory drug

Purposes

Pain reliever
Pain reliever aid

Uses

temporarily relieves minor aches and pains due to

  • Headache
  • toothache
  • muscular aches
  • a cold
  • backache
  • 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

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 nonprescription 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 diuretic
  • 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

  • an allergic reaction occurs. Seek medical help right away.
  • 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

  • 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 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
  • children under 12 years of age: do not use

Other information

Keep carton fo r full drug facts and warnings.

Store at 15 – 25°C (59– 77°F). Protect from moisture.

Inactive ingredients

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

Questions?

1-800-344-7239 anacin.com

PRINCIPAL DISPLAY PANEL

ANACIN ®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

ANACIN®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid
100 COATED TABLETS
(click image for full-size original)

ANACIN asprin and caffeine tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63736-200
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (ASPIRIN) ASPIRIN 400 mg
CAFFEINE (CAFFEINE) CAFFEINE 32 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
CELLULOSE, MICROCRYSTALLINE
SODIUM LAURYL SULFATE
STARCH, CORN
POLYETHYLENE GLYCOL, UNSPECIFIED
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63736-200-04 1 BLISTER PACK in 1 BOX contains a BLISTER PACK
1 4 TABLET in 1 BLISTER PACK This package is contained within the BOX (63736-200-04)
2 NDC:63736-200-93 1 BOTTLE in 1 BOX contains a BOTTLE
2 300 TABLET in 1 BOTTLE This package is contained within the BOX (63736-200-93)
3 NDC:63736-200-30 1 BOTTLE in 1 BOX contains a BOTTLE
3 30 TABLET in 1 BOTTLE This package is contained within the BOX (63736-200-30)
4 NDC:63736-200-50 1 BOTTLE in 1 BOX contains a BOTTLE
4 50 TABLET in 1 BOTTLE This package is contained within the BOX (63736-200-50)
5 NDC:63736-200-90 1 BOTTLE in 1 BOX contains a BOTTLE
5 100 TABLET in 1 BOTTLE This package is contained within the BOX (63736-200-90)
6 NDC:63736-200-91 1 BOTTLE in 1 BOX contains a BOTTLE
6 130 TABLET in 1 BOTTLE This package is contained within the BOX (63736-200-91)
7 NDC:63736-200-92 125 POUCH in 1 BOX contains a POUCH
7 1 TABLET in 1 POUCH This package is contained within the BOX (63736-200-92)
8 NDC:63736-200-95 750 POUCH in 1 BOX contains a POUCH
8 1 TABLET in 1 POUCH This package is contained within the BOX (63736-200-95)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 06/25/2009
Labeler — Insight Pharmaceuticals LLC (055665422)

Revised: 07/2020 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.

Medication Sections

Medication Information by RSS

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.

Terms of Use | Copyright © 2020. All Rights Reserved.