FDA.reportPublic FDA data

Anacin

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2025-10-23
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:40:10

Label at a glance#

ProductAnacin
Active ingredientASPIRIN, CAFFEINE
Label structure10 sections

Indications and uses

temporarily relieves minor aches and pains due to Headache toothache muscular aches a cold backache arthritis menstrual cramps

Dosage and administration

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 Keep carton fo r full drug facts and warnings. Store at 15 – 25°C (59– 77°F). Protect from moisture.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ANACIN- asprin and caffeine tablet Insight Pharmaceuticals

ANACIN®

Drug Facts

Active ingredients (per tablet)

OTC - ACTIVE INGREDIENT SECTION

Aspirin (NSAID)* 400 mg
Caffeine 32 mg

* 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
  • toothache
  • muscular aches
  • a cold
  • backache
  • arthritis
  • 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 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.

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

OTC - ASK DOCTOR SECTION

  • 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

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

you are taking a prescription drug for

  • diabetes
  • gout
  • arthritis

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 SAFETY INFORMATION

Keep carton for full drug facts and warnings.

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-344-7239 anacin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.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 TABLETSANACIN® Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid 100 COATED TABLETS

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ANACIN®

Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid

300 COATED TABLETS

ANACIN® Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid 300 COATED TABLETSANACIN® Aspirin (NSAID) Pain Reliever / Caffeine Pain Reliever Aid 300 COATED TABLETS

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
211292ANACIN 400 MG / 32 MG Oral TabletPSN9
198479aspirin 400 MG / caffeine 32 MG Oral TabletPSN9
211292aspirin 400 MG / caffeine 32 MG Oral Tablet [Anacin]SBD9
198479aspirin 400 MG / caffeine 32 MG Oral TabletSCD9
211292Anacin (ASA 400 MG / caffeine 32 MG) Oral TabletSY9
198479ASA 400 MG / Caffeine 32 MG Oral TabletSY9
211292ASA 400 MG / Caffeine 32 MG Oral Tablet [Anacin]SY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASPIRIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20191108
CAFFEINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-200-04Anacin1 in 1 BOXTABLET19
63736-200-04Anacin4 in 1 BLISTER PACKTABLET49
63736-200-30Anacin1 in 1 BOXTABLET19
63736-200-30Anacin30 in 1 BOTTLETABLET309
63736-200-50Anacin1 in 1 BOXTABLET19
63736-200-50Anacin50 in 1 BOTTLETABLET509
63736-200-90Anacin100 in 1 BOTTLETABLET1009
63736-200-90Anacin1 in 1 BOXTABLET19
63736-200-91Anacin1 in 1 BOXTABLET19
63736-200-91Anacin130 in 1 BOTTLETABLET1309
63736-200-92Anacin125 in 1 BOXTABLET1259
63736-200-92Anacin1 in 1 POUCHTABLET19
63736-200-93Anacin300 in 1 BOTTLETABLET3009
63736-200-93Anacin1 in 1 BOXTABLET19
63736-200-95Anacin750 in 1 BOXTABLET7509
63736-200-95Anacin1 in 1 POUCHTABLET19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AspirinACTIVE INGREDIENTR16CO5Y76E2
CaffeineACTIVE INGREDIENT3G6A5W338E2
AspirinACTIVE MOIETYR16CO5Y76E2
CaffeineACTIVE MOIETY3G6A5W338E2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61U2
hypromellosesINACTIVE INGREDIENT3NXW29V3WO2
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141J2

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-20063736-200-30, 63736-200-50, 63736-200-90, 63736-200-91, 63736-200-92, 63736-200-93, 63736-200-95, 63736-200-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASPIRINR16CO5Y76EACTIB
CAFFEINE3G6A5W338EACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
HYPROMELLOSES3NXW29V3WOIACT
MINERAL OILT5L8T28FGPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
STARCH, CORNO8232NY3SJIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82025-01-16full-release2026-06-01 00:52:35

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 1 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
sodium lauryl sulfateSODIUM LAURYL SULFATE368GB5141JTABLET / ORAL233 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
hypromellosesHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
9 equally ranked IID candidates
cellulose, microcrystallineMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii+route+dosage form
9 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
AnacinASPRIN AND CAFFEINEInsight Pharmaceuticals LLC51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff2025-10-23WarningsExact identifier
ndc (package): 63736-200-91
ndc (package): 63736-200-30
ndc (package): 63736-200-50
ndc (package): 63736-200-04
ndc (package): 63736-200-92
ndc (package): 63736-200-95
ndc (package): 63736-200-90
ndc (package): 63736-200-93
ndc (product): 63736-200
ndc11 (package): 63736020030
ndc11 (package): 63736020090
ndc11 (package): 63736020091
ndc11 (package): 63736020093
ndc11 (package): 63736020050
ndc11 (package): 63736020092
ndc11 (package): 63736020004
ndc11 (package): 63736020095
spl id: 4895609d-1ec8-4ebd-8b6e-61ccd452ad5b
spl set id: 51ab0ee3-3c94-424d-a30a-2d6c14e3d8ff

Reported adverse events (FAERS/openFDA)#

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