EXAPRIN
- Manufacturer
- HART Health
- Effective date
- 2019-11-30
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:02:02
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients (in each tablet):
Acetaminophen 110mg
Aspirin (NSAID*) 162mg (*nonsteroidal anti-inflammatory drug)
Caffeine 32.4mg
Salicylamide (NSAID)* 152mg (*nonsteroidal anti-inflammatory drug)
OTC - PURPOSE SECTION
Purpose:
Pain Reliever / Fever Reducer
Pain Reliever / Fever Reducer
Pain Reliever Aid
Pain Reliever / Fever Reducer
INDICATIONS & USAGE SECTION
Uses:
Temporarily relieves minor aches and pains due to
- headache
- backache
- muscular aches
- minor arthritis pain
- the common cold
- toothache
- menstrual cramps
Temporarily reduces fever
WARNINGS SECTION
Warnings:
Reye's syndrome: Children and teenagers should not use this medicine for chicken pox or flu symptoms before a doctor is consulted about Reye's syndrome, a rare but serious illness reported to be associated with aspirin.
Allergy alert: Acetaminophen and aspirin may cause severe allergic reactions which may include hives, skin reddening, blisters, rash, facial swelling, asthma (wheezing), or shock
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other products containing acetaminophen
- 3 more more alcoholic drinks every day while using this product
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 more or for a longer time than directed
- take a blood thinning (anticoagulant) or steroid drug
- have 3 or more alcohol drinks every day while using this product
- take other drugs containing prescription or non-prescription NSAIDS (aspirin, ibuprofen, naproxen, others)
OTC - DO NOT USE SECTION
Do not use
- with any other drug containing acetaminophen (prescription or non-prescription)
- if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer
OTC - ASK DOCTOR SECTION
Ask a doctor before use if
- stomach bleeding warning applies to you
- you have asthma, high blood pressure, heart disease, liver cirrhosis, or kidney disease
- you are taking a diuretic
- you have a history of stomach problems, such as heartburn
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you
- take any other drug containing an NSAID
- take a blood thinning (anticoagulant) or steroid drug
- take any drug for diabetes, gout, or arthritis
- do not know if other drugs you are taking contain acetaminophen
OTC - STOP USE SECTION
Stop use and ask a doctor if
- an allergic reaction occurs, seek medical help right away
- new symptoms occur
- fever worsens or lasts more than 3 days
- pain worsens or lasts more than 10 days
- redness or swelling is present
- ringing in the ears or a loss of hearing occurs
- you have any of the following signs of stomach bleeding: feel faint, vomit blood, or have bloody or black stools, or stomach pain that does not get better
These could be signs of a serious condition
OTC - PREGNANCY OR BREAST FEEDING SECTION
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 is may cause problems in the unborn child or complications during delivery
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
OVERDOSAGE SECTION
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms. In case of overdose, get medical help or contact a Poison Control Center right away. 1-800-222-1222
DOSAGE & ADMINISTRATION SECTION
Directions:
do not take more than directed.
Adults and children 12 years of age and over:
- take 1 or 2 tablets with water every 4 hours while sympotms persist
- do not take more than 8 tablets in 24 hours unless directed by a doctor
Children under 12 years of age: ask a doctor
INACTIVE INGREDIENT SECTION
Inactive Ingredients:
FD&C Yellow #6, Magnesium Stearate, Microcrystalline Cellulose, Povidone, Starch, Stearic Acid
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 359221 | acetaminophen 110 MG / aspirin 162 MG / salicylamide 152 MG / caffeine 32.4 MG Oral Tablet | PSN | 3 |
| 1358853 | EXAPRIN Extra-Strength Pain Reliever 110 MG / 162 MG / 32.4 MG / 152 MG Oral Tablet | PSN | 3 |
| 1358853 | acetaminophen 110 MG / aspirin 162 MG / caffeine 32.4 MG / salicylamide 152 MG Oral Tablet [Exaprin] | SBD | 3 |
| 359221 | acetaminophen 110 MG / aspirin 162 MG / caffeine 32.4 MG / salicylamide 152 MG Oral Tablet | SCD | 3 |
| 359221 | APAP 110 MG / ASA 162 MG / Caffeine 32.4 MG / salicylamide 152 MG Oral Tablet | SY | 3 |
| 1358853 | APAP 110 MG / ASA 162 MG / Caffeine 32.4 MG / salicylamide 152 MG Oral Tablet [Exaprin] | SY | 3 |
| 1358853 | Exaprin (APAP 110 MG / ASA 162 MG / caffeine 32.4 MG / salicylamide 152 MG) Oral Tablet | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ASPIRIN Pharmacologic Class Indexing | 3 | Indexing - Pharmacologic Class | 20191108 |
| CAFFEINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 50332-0105-3 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-34fe-a910-e053-dadaa90a0b85 | EXAPRIN |
| 50332-0105-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-34fe-a910-e053-dadaa90a0b85 | EXAPRIN |
| 50332-0105-7 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-34fe-a910-e053-dadaa90a0b85 | EXAPRIN |
| 50332-0105-8 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-34fe-a910-e053-dadaa90a0b85 | EXAPRIN |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 50332-0105 | EXAPRIN (ACETAMINOPHEN, ASPIRIN, CAFFEINE, SALICYLAMIDE) TABLET [HART HEALTH] | 3 | Legacy NDC | 20191217_9fe82229-cc3e-4d79-a448-014fe3d0055b.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ACETAMINOPHEN | ACTIVE INGREDIENT | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE INGREDIENT | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE INGREDIENT | 3G6A5W338E | 1 | |
| SALICYLAMIDE | ACTIVE INGREDIENT | EM8BM710ZC | 1 | |
| ACETAMINOPHEN | ACTIVE MOIETY | 362O9ITL9D | 1 | |
| ASPIRIN | ACTIVE MOIETY | R16CO5Y76E | 1 | |
| CAFFEINE | ACTIVE MOIETY | 3G6A5W338E | 1 | |
| SALICYLAMIDE | ACTIVE MOIETY | EM8BM710ZC | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | 1 | |
| POVIDONE | INACTIVE INGREDIENT | FZ989GH94E | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | 1 | |
| STEARIC ACID | INACTIVE INGREDIENT | 4ELV7Z65AP | 1 |
Products#
Every source-derived product name is available through these pages.
- EXAPRIN
- acetaminophen, aspirin, caffeine, salicylamide
- ACETAMINOPHEN
- ASPIRIN
- CAFFEINE
- SALICYLAMIDE
- STARCH, CORN
- FD&C YELLOW NO. 6
- MAGNESIUM STEARATE
- CELLULOSE, MICROCRYSTALLINE
- POVIDONE
- STEARIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 50332-0105 | 50332-0105-3, 50332-0105-4, 50332-0105-7, 50332-0105-8 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPIRIN | R16CO5Y76E | ACTIB |
| CAFFEINE | 3G6A5W338E | ACTIB |
| SALICYLAMIDE | EM8BM710ZC | ACTIB |
| STARCH, CORN | O8232NY3SJ | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| POVIDONE | FZ989GH94E | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, CHEWABLE / ORAL | 180 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET, FILM COATED / ORAL | 992 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | POWDER, FOR SOLUTION / ORAL | 40 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, EXTENDED RELEASE / ORAL | 4.59 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / BUCCAL | 6 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 21 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED / ORAL | 176 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | DROPS / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 120 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | POWDER, FOR SUSPENSION / ORAL | 4441 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION / ORAL | 11 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | CAPSULE, COATED PELLETS / ORAL | 10.03 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | SHAMPOO / TOPICAL | 9.7 %w/w | ||
| POVIDONE | POVIDONE | FZ989GH94E | FILM, EXTENDED RELEASE / TRANSDERMAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET, COATED / ORAL | 3.17 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | SUSPENSION / ORAL | 900 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | INHALANT / ORAL | 0.08 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | LIQUID / ORAL | 0.2 mg/1ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SUSPENSION, EXTENDED RELEASE / ORAL | 0.12 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, CHEWABLE / ORAL | 48 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TROCHE / ORAL | 30 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, CHEWABLE / ORAL | 127 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER, FOR SUSPENSION / ORAL | 120 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, EXTENDED RELEASE / ORAL | 101 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | GRANULE, FOR SUSPENSION / ORAL | 14 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | TABLET / ORAL | 60.02 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE, EXTENDED RELEASE / ORAL | 64 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SOLUTION / ORAL | 75.3 mg/15ml | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / TOPICAL | 190 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, CHEWABLE / ORAL | 180 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / TOPICAL | 104 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CAPSULE / ORAL | 90 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET, COATED / ORAL | 42.4 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET / ORAL | 1116 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, DELAYED RELEASE / ORAL | 53 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | CAPSULE, EXTENDED RELEASE / ORAL | 194 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE, DELAYED RELEASE / ORAL | 0.02 mg | ||
| STARCH, CORN | STARCH, CORN | O8232NY3SJ | TABLET, COATED / ORAL | 256 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 47 mg | ||
| CELLULOSE, MICROCRYSTALLINE | MICROCRYSTALLINE CELLULOSE | OP1R32D61U | TABLET / BUCCAL | 18 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | IMPLANT / SUBCUTANEOUS | 0.5 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | NA | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / SUBLINGUAL | 9 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | TABLET, ORALLY DISINTEGRATING / ORAL | 187 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | LOZENGE / ORAL | 420 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SPONGE / TOPICAL | 0.01 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | OINTMENT / TOPICAL | 15 %w/w | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | CREAM / VAGINAL | 1088 mg | ||
| STEARIC ACID | STEARIC ACID | 4ELV7Z65AP | TABLET / ORAL | 336 mg | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CONCENTRATE / ORAL | 0.03 mg/5ml | ||
| POVIDONE | POVIDONE | FZ989GH94E | SUSPENSION / AURICULAR (OTIC) | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET / ORAL | 216 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, COATED / ORAL | 49.2 mg | ||
| POVIDONE | POVIDONE | FZ989GH94E | TABLET, ORALLY DISINTEGRATING / ORAL | 15.03 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | CREAM / TOPICAL | NA | ||
| POVIDONE | POVIDONE | FZ989GH94E | POWDER, FOR SUSPENSION / ORAL | 35 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | SYRUP / ORAL | 4 mg/5ml | ||
| FD&C YELLOW NO. 6 | FD&C YELLOW NO. 6 | H77VEI93A8 | CAPSULE / ORAL | 7 mg | ||
| MAGNESIUM STEARATE | MAGNESIUM STEARATE | 70097M6I30 | POWDER / RESPIRATORY (INHALATION) | 0.13 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1d1061d7-0116-43a5-9503-f101f28c7fc6 | 9fe82229-cc3e-4d79-a448-014fe3d0055b | 2019-11-30 | Warnings | 1d1061d7-0116-43a5-9503-f101f28c7fc6 9fe82229-cc3e-4d79-a448-014fe3d0055b |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
