PAIN TERMINATOR 2 SEVERE

Manufacturer
Provision Medical Products | ULTRAtab Laboratories, Inc.
Effective date
2023-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:41:31

Label at a glance#

ProductPAIN TERMINATOR 2 SEVERE
Active ingredientASPIRIN, ACETAMINOPHEN
Label structure9 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Uses:

for temporary relief of mild to moderate pain

associated with headache.

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 SPECIFICALLY

DIRECTED TO DO SO BY A DOCTOR,

BECAUSE IT 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. In

case of overdose, get medical help or

contact a Poison Control Center right

away. Prompt medical attention is

critical for adults as well as for children

even if you do not notice any signs or

symptoms.

WARNINGS SECTION

Warnings:

Reye's syndrome: Children and teenagers should not

use this medicine for chicken pox or  u symptoms

before a doctor is consulted about Reye's syndrome, a

rare but serious illness reported to be associated with

aspirin.

Allergy Alert: Do not take this product if after

taking a pain reliever or fever reducer you ever had • hives • facial swelling • asthma • shock

Alcohol Warning: If you consume 3 or more

alcoholic drinks every day, ask your doctor whether you

should take acetaminophen and aspirin or other pain

relievers/fever reducers. Acetaminophen and aspirin may

cause liver damage and stomach bleeding.

Ask a doctor before use if you have: • the worst headache of your life • ulcers

• fever and sti neck • asthma

• bleeding problems • liver disease

• renal disease

When using this product:

• limit the use of caffeine containing medications,

foods, or beverages while taking this product

because too much caFFeine may cause

nervousness, sleeplessness, irritability and,

occasionally, rapid heart beat.

Stop use and ask a doctor if:

• headache pain worsens or continues for more than 48 hours

• new or unexpected symptoms occur

• ringing in the ears or loss of hearing occur

DOSAGE & ADMINISTRATION SECTION

Directions:

Adults and children 12 years of age, no to exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years: Do not give to children under 12 unless directed by a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

cellulose, pharmaceutical glaze,

povidone, starch, stearic acid and talc

USP.

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT-ACETAMINOPHEN 250 MG, ASPIRIN 250 MG,CAFFEINE 65 mg

OTC - PURPOSE SECTION

PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PAIN TERMINATOR SEVERE BOXPAIN TERMINATOR SEVERE BOX

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D1
ASPIRINACTIVE INGREDIENTR16CO5Y76E1
ACETAMINOPHENACTIVE MOIETY362O9ITL9D1
ASPIRINACTIVE MOIETYR16CO5Y76E1
CAFFEINEINACTIVE INGREDIENT3G6A5W338E1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
POVIDONE K30INACTIVE INGREDIENTU725QWY32X1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6B1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69103-253369103-2533-5, 69103-2533-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

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
POVIDONE K30POVIDONE K30U725QWY32XTABLET / ORAL2828 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJCAPSULE, COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SUSPENSION / ORAL4441 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APLOTION / TOPICAL80 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, CHEWABLE / ORAL245 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, EXTENDED RELEASE / ORAL200 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJSUSPENSION / ORAL900 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE / ORAL202 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJDROPS / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / BUCCAL1 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338ESPRAY, METERED / NASAL10 mg/1mlExact identifier — unii candidate
3 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APAEROSOL, FOAM / TOPICAL8 %w/wExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSYSTEM / TRANSDERMAL15 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, DELAYED RELEASE PELLETS / ORAL178 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XPOWDER, FOR SOLUTION / ORAL2832 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XLOZENGE / ORAL700 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED, EXTENDED RELEASE / ORAL615 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET / SUBLINGUAL30 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, COATED / ORAL160 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSUSPENSION / OPHTHALMIC14 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE PARTICLES / ORAL580 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, EXTENDED RELEASE / ORAL368 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSOLUTION / ORAL300 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XSOLUTION/ DROPS / OPHTHALMIC4 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET / BUCCAL16.6 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XAEROSOL, FOAM / TOPICAL1.9 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APSOLUTION / TOPICALNAExact identifier — unii candidate
26 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCAPSULE / ORAL90 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XGRANULE, EFFERVESCENT / ORAL40 mgExact identifier — unii candidate
40 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, COATED / ORAL42.4 mgExact identifier — unii candidate
26 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTROCHE / ORAL175 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, DELAYED RELEASE / ORAL516 mgExact identifier — unii candidate
40 equally ranked IID candidates
CAFFEINECAFFEINE3G6A5W338EGRANULE / ORALNAExact identifier — unii candidate
3 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XPOWDER / ORAL378 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XTABLET, DELAYED RELEASE PARTICLES / ORAL70 mgExact identifier — unii candidate
40 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE, COATED, EXTENDED RELEASE / ORAL15 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UIMPLANT / INTRAVITREAL1.66 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UCAPSULE / ORAL2169 mgExact identifier — unii candidate
28 equally ranked IID candidates
POVIDONE K30POVIDONE K30U725QWY32XCAPSULE / ORAL540 mgExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APPOWDER, FOR SUSPENSION / ORAL1203 mg/5mlExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJPOWDER, FOR SUSPENSION / ORAL34 mgExact identifier — unii candidate
22 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UPOWDER, FOR SOLUTION / ORAL690 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, ORALLY DISINTEGRATING / ORAL1800 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, CHEWABLE / ORAL180 mgExact identifier — unii candidate
26 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE, FOR SUSPENSION / ORAL278 mgExact identifier — unii candidate
28 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APCREAM / VAGINAL1088 mgExact identifier — unii candidate
26 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL21 mgExact identifier — unii candidate
22 equally ranked IID candidates
STARCH, PREGELATINIZED CORNSTARCH, CORNO8232NY3SJTABLET, DELAYED RELEASE / ORAL713 mgExact identifier — unii candidate
22 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
f18ec92d-392b-bfa5-e053-2a95a90a4545715d92bc-7df2-4f7d-bc91-305c4c4c54e42023-01-05WarningsExact identifier
spl id: f18ec92d-392b-bfa5-e053-2a95a90a4545
spl set id: 715d92bc-7df2-4f7d-bc91-305c4c4c54e4

Reported adverse events (FAERS/openFDA)#

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