Anacin - 63736-200

Anacin - 63736-200
SPL v9
SPL
SPL Set ID 51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff
Route
ORAL
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aspirin (400 mg) Caffeine (32 mg)
Inactive Ingredients
Croscarmellose Sodium Hypromelloses Mineral Oil Silicon Dioxide Sodium Lauryl Sulfate Starch, Corn Stearic Acid Talc Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance
Shape: round Color: white Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-06-25 Until 2023-06-30

Description

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals ANACIN ® Drug Facts

Purpose

Pain reliever Pain reliever aid


Medication Information

Purpose

Pain reliever Pain reliever aid

Description

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals ANACIN ® Drug Facts

Uses

temporarily relieves minor aches and pains due to

  • Headache

  • toothache

  • muscular aches

  • a cold

  • backache

  • arthritis

  • menstrual cramps
Section 42229-5

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN ®

Drug Facts

Purposes

Pain reliever

Pain reliever aid

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

Caffeine warning

This product contains caffeine. 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 heartbeat.

Directions
  • 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
Do Not Use

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

Questions?

1-800-344-7239 anacin.com

Overdose Warning

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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, croscarmellose sodium, hypromellose, mineral oil, , silicon dioxide, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

Principal Display Panel

ANACIN ®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

Ask A Doctor Before Use If
  • the 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
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

  • These may be signs of a serious condition
If Pregnant Or Breast Feeding,

ask a health professional before use. It is especially important not to use aspirin at least 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active Ingredients (per Tablet)

Aspirin (NSAID)* 400 mg

Caffeine 32 mg

* nonsteroidal anti- inflammatory drug

Ask A Doctor Or Pharmacist Before Use If

you are taking a prescription drug for

  • diabetes

  • gout

  • arthritis

Structured Label Content

Uses

temporarily relieves minor aches and pains due to

  • Headache

  • toothache

  • muscular aches

  • a cold

  • backache

  • arthritis

  • menstrual cramps
Section 42229-5 (42229-5)

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN ®

Drug Facts

Purposes

Pain reliever

Pain reliever aid

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

Caffeine warning

This product contains caffeine. 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 heartbeat.

Directions
  • 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
Do Not Use (Do not use)

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

Questions?

1-800-344-7239 anacin.com

Overdose Warning (Overdose warning)

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Other Information (Other information)

Keep carton fo r full drug facts and warnings.

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

Inactive Ingredients (Inactive ingredients)

corn starch, croscarmellose sodium, hypromellose, mineral oil, , silicon dioxide, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ANACIN ®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

Ask A Doctor Before Use If (Ask a doctor before use if)
  • the 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
Stop Use and Ask A Doctor If (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

  • These may be signs of a serious condition
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use. It is especially important not to use aspirin at least 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Active Ingredients (per Tablet) (Active ingredients (per tablet))

Aspirin (NSAID)* 400 mg

Caffeine 32 mg

* nonsteroidal anti- inflammatory drug

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

you are taking a prescription drug for

  • diabetes

  • gout

  • arthritis

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)