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.

----------

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 Type HUMAN OTC DRUG Item Code (Source) NDC:69103-2533
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg
Inactive Ingredients
Ingredient Name Strength
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
Color white (SNOW WHITE) Score no score
Shape ROUND Size 11mm
Flavor Imprint Code FR9
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:69103-2533-5 250 in 1 CARTON 04/03/2015
1 2 in 1 PACKET; Type 0: Not a Combination Product
2 NDC:69103-2533-6 100 in 1 CARTON 04/03/2015
2 2 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/03/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
Name Address ID/FEI Business Operations
Ultraseal Corporation 085752004 pack(69103-2533)
Establishment
Name Address ID/FEI Business Operations
ULTRAtab Laboratories, Inc. 151051757 manufacture(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