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

Purpose

Pain reliever Pain reliever aid

Description

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


Medication Information

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.

Uses

temporarily relieves minor aches and pains due to

  • Headache

  • toothache

  • muscular aches

  • a cold

  • backache

  • arthritis

  • menstrual cramps
Purpose

Pain reliever Pain reliever aid

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
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

Description

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

Principal Display Panel

ANACIN ®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

100 COATED TABLETS

Questions?

1-800-344-7239 anacin.com

Section 42229-5

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN ®

Drug Facts

Purposes

Pain reliever

Pain reliever aid

Do Not Use

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

Overdose Warning

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

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

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.

Uses

temporarily relieves minor aches and pains due to

  • Headache

  • toothache

  • muscular aches

  • a cold

  • backache

  • arthritis

  • menstrual cramps
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
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

Questions?

1-800-344-7239 anacin.com

Section 42229-5 (42229-5)

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN ®

Drug Facts

Purposes

Pain reliever

Pain reliever aid

Do Not Use (Do not use)

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

Overdose Warning (Overdose warning)

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

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

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