PAIN TERMINATOR 2 SEVERE- aspirin, acetaminophen, caffeine tablet 
Provision Medical Products

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Uses:

for temporary relief of mild to moderate pain

associated with headache.

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.

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:

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

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 Ingredients:

cellulose, pharmaceutical glaze,

povidone, starch, stearic acid and talc

USP.

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

PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

PAIN TERMINATOR SEVERE BOX

PAIN TERMINATOR 2 SEVERE 
aspirin, acetaminophen, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2533
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
Inactive Ingredients
Ingredient NameStrength
CAFFEINE (UNII: 3G6A5W338E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
Product Characteristics
Colorwhite (SNOW WHITE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR9
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2533-5250 in 1 CARTON04/03/2015
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69103-2533-6100 in 1 CARTON04/03/2015
22 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/03/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(69103-2533)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2533)

Revised: 4/2015
Document Id: ece58542-7009-405a-adeb-e8889525f331
Set id: 715d92bc-7df2-4f7d-bc91-305c4c4c54e4
Version: 1
Effective Time: 20150404
 
Provision Medical Products