FDA.reportPublic FDA data

Anacin

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2020-07-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 23:23:58

Label at a glance#

ProductAnacin ES
Active ingredientAspirin, Caffeine
Label structure11 sections

Indications and uses

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

Dosage and administration

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 over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor children under 12 years: ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ANACIN®

Drug Facts

Active ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin (NSAID)1 500 mg

Caffeine 32 mg

1

nonsteroidal anti-inflammatory drug

Purposes

OTC - PURPOSE SECTION

Pain reliever

Pain reliever aid

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • muscular aches
  • arthritis
  • toothache
  • menstrual cramps

Warnings

WARNINGS SECTION

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 a nonsteroidal anti-inflammatory drug (NSAID), which may cause 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 an NSAID (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

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • asthma
  • ulcers
  • bleeding problems
  • stomach problems that last or come back, such as heartburn, upset stomach, or stomach pain
  • high blood pressure
  • heart or kidney disease
  • taken a diuretic
  • reached age 60 or older

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking any other drug containing an NSAID (prescription or nonprescription)
  • taking a blood thinning (anticoagulant) or steroid drug
  • taking a prescription drug for diabetes, gout, or arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • an allergic reaction occurs. Seek medical help right away.
  • new symptoms occur
  • you feel faint, vomit blood, or have bloody or black stools. These are signs of stomach bleeding.
  • stomach pain or upset gets worse or lasts
  • ringing in the ears or loss of hearing occurs
  • painful area is red or swollen
  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
Caffeine warning

SPL UNCLASSIFIED SECTION

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning

OVERDOSAGE SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 over: take 2 tablets every 6 hours; not more than 8 tablets in 24 hours, or as directed by a doctor
  • children under 12 years: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Keep carton for full drug facts. Read all warnings and directions before use. Store at 20° − 25°C (68° − 77°F). Protect from moisture.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Distr. by: INSIGHT Pharmaceuticals Corp.
Langhorne, PA 19047-1749

Questions?

OTC - QUESTIONS SECTION

Call 1-800-344-7239 or visit our website at www.anacin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

- 75 Tablet Bottle Carton

Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing.

ANACIN®
ASPIRIN + CAFFEINE = FAST PAIN RELIEF

Pain Reliever (NSAID) + Pain Reliever Aid

MAX STRENGTH

75
COATED
TABLETS

SEE NEW WARNINGS INFORMATION

PRINCIPAL DISPLAY PANEL - 75 Tablet Bottle Carton Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing. ANACIN® ASPIRIN + CAFFEIN...PRINCIPAL DISPLAY PANEL - 75 Tablet Bottle Carton Do Not Use if seal under bottle cap imprinted with "SEALED for YOUR PROTECTION" is broken or missing. ANACIN® ASPIRIN + CAFFEIN...

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-211-402020-06-29C16284748780-19d75b9cf-d42a-f424-e053-dadaa90a57ceAnacin Max - 63736-211
63736-211-752020-06-29C16284748780-19d75b9cf-d42a-f424-e053-dadaa90a57ceAnacin Max - 63736-211
63736-211-402020-01-31C16284748780-19d75b9cf-d42a-f424-e053-dadaa90a57ceAnacin Max - 63736-211
63736-211-752020-01-31C16284748780-19d75b9cf-d42a-f424-e053-dadaa90a57ceAnacin Max - 63736-211

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AspirinACTIVE INGREDIENTR16CO5Y76E2
CaffeineACTIVE INGREDIENT3G6A5W338E2
AspirinACTIVE MOIETYR16CO5Y76E2
CaffeineACTIVE MOIETY3G6A5W338E2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
hypromellosesINACTIVE INGREDIENT3NXW29V3WO2
polyethylene glycolINACTIVE INGREDIENT3WJQ0SDW1A2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J2
starch, cornINACTIVE INGREDIENTO8232NY3SJ2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-21163736-211-40, 63736-211-75

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
AspirinR16CO5Y76EACTIB
Caffeine3G6A5W338EACTIB
starch, cornO8232NY3SJIACT
hypromelloses3NXW29V3WOIACT
cellulose, microcrystallineOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
sodium lauryl sulfate368GB5141JIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 119 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
hypromellosesHYPROMELLOSE3NXW29V3WOSUSPENSION / ORAL305 mgExact identifier — unii candidate
27 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE, DELAYED RELEASE / ORAL105 mgExact identifier — unii candidate
27 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, DELAYED RELEASE / ORAL199 mgExact identifier — unii candidate
42 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCREAM / VAGINAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOGRANULE / ORAL45 mgExact identifier — unii candidate
27 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJCONCENTRATE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, CHEWABLE / ORAL11.8 mgExact identifier — unii candidate
27 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FILM COATED / ORAL240 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, ORALLY DISINTEGRATING / ORAL16 mgExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii candidate
27 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPOWDER / VAGINAL3 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPELLET / ORAL2 mgExact identifier — unii candidate
42 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJSUSPENSION/ DROPS / ORAL90 mgExact identifier — unii candidate
22 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE / ORAL1725 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, CHEWABLE, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, COATED / ORAL123 mgExact identifier — unii candidate
42 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, EFFERVESCENT / ORAL1.5 mgExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOLOTION / TOPICAL0.1 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii candidate
22 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET / SUBLINGUAL409 mgExact identifier — unii candidate
22 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, DELAYED RELEASE / ORAL79 mgExact identifier — unii candidate
27 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JCAPSULE, COATED PELLETS / ORAL1 mgExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGRANULE / ORAL12 mgExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET, COATED / ORAL58 mgExact identifier — unii candidate
27 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPOWDER, FOR SUSPENSION / ORAL64 mgExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
27 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, EXTENDED RELEASE / ORAL184 mgExact identifier — unii candidate
22 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJSUSPENSION, EXTENDED RELEASE / ORAL113 mgExact identifier — unii candidate
22 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSUSPENSION / ORAL705 mgExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, COATED / ORAL920 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSPONGE / TOPICAL5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOGEL / RECTAL348 mgExact identifier — unii candidate
27 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET, FOR SUSPENSION / ORAL264 mgExact identifier — unii candidate
42 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJPASTILLE / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSHAMPOO / TOPICAL65 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL1576 mgExact identifier — unii candidate
28 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JINSERT / VAGINAL15 mgExact identifier — unii candidate
42 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JSHAMPOO, SUSPENSION / TOPICAL40 %w/vExact identifier — unii candidate
42 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JPASTE / DENTAL1.5 %w/wExact identifier — unii candidate
42 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPELLET / ORAL1140 mgExact identifier — unii candidate
28 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
starch, cornSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOCAPSULE / ORAL1488 mgExact identifier — unii candidate
27 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, DELAYED RELEASE / ORAL789.6 mgExact identifier — unii candidate
28 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d48a0ffa-723f-4534-9a23-6e11beaab2c9dd10572f-a3cc-4341-a690-73061c210ee22020-07-02WarningsExact identifier
spl id: d48a0ffa-723f-4534-9a23-6e11beaab2c9
spl set id: dd10572f-a3cc-4341-a690-73061c210ee2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.