PAIN TERMINATOR- aspirin, acetaminophen, caffeine, salicylamide 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:

temporarily relieves minor aches and pains

associated with: • backache • toothache • colds • headaches • muscular aches • menstrual cramps • minor arthritis pain

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.

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.

Do not use:• if you are allergic to aspirin • with any other pain reliever/fever reducer • if you have ever had an allergic reaction to any

other pain reliever/fever reducer

• for pain for more than 10 days or for fever for more than 3 days unless directed by a doctor

• with any other product containing acetaminophen

Ask a doctor before using if you have:

• asthma • gastric ulcers • bleeding problems • stomach problems (such as heartburn, upset stomach or stomach pain)

Ask a doctor or pharmacist before use if you are taking a prescription drug for: • anticoagulation (thinning of blood)

• diabetes • gout • arthritis

Stop use and ask a doctor if: • ringing in the ears or loss of hearing occurs • pain or fever persists or gets worse

• new symptoms occur • redness or swelling is present

When using this product do not exceed

recommended dose.

Directions:

Adults and children 12 years of age and older take 2 tablets

every 4 hours  for pain as needed, do not exceed 8 tablets in 24 hours, or as directed by a doctor.

Children under 12 years consult a doctor.

Inactive Ingredients:

FD&C yellow #6, magnesium stearate,

microcrystalline cellulose, povidone,

starch, and stearic acid.

ACTIVE INGREDIENT-ACETAMINOPHEN 110 MG, ASPIRIN 162 MG,CAFFEINE 32.4MG, SALICYLAMIDE  152 MG

PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

image description

PAIN TERMINATOR 
aspirin, acetaminophen, caffeine, salicylamide tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69103-2507
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN162 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC) SALICYLAMIDE152 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN110 mg
Inactive Ingredients
Ingredient NameStrength
CAFFEINE (UNII: 3G6A5W338E)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
POVIDONE K30 (UNII: U725QWY32X)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
Colorblue (SKY BLUE) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code FR2
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69103-2507-5250 in 1 CARTON04/03/2015
12 in 1 PACKET; Type 0: Not a Combination Product
2NDC:69103-2507-6100 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 finalpart34303/31/2015
Labeler - Provision Medical Products (036936831)
Registrant - Provision Medical Products (036936831)
Establishment
NameAddressID/FEIBusiness Operations
Ultraseal Corporation085752004pack(69103-2507)
Establishment
NameAddressID/FEIBusiness Operations
ULTRAtab Laboratories, Inc.151051757manufacture(69103-2507)

Revised: 4/2015
Document Id: 2e873528-b9a9-45c6-b995-ffdf527a3494
Set id: 54b10f1d-8988-4f2f-88f8-49ee9d2cb96e
Version: 1
Effective Time: 20150403
 
Provision Medical Products