PAIN TERMINATOR- aspirin, acetaminophen, caffeine, salicylamide tablet

PAIN TERMINATOR by

Drug Labeling and Warnings

PAIN TERMINATOR by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, Ultraseal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Uses:

temporarily relieves minor aches and pains

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

PREGNANCY OR BREAST FEEDING

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

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

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients:

FD&C yellow #6, magnesium stearate,

microcrystalline cellulose, povidone,

starch, and stearic acid.

ACTIVE INGREDIENT

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

PURPOSE

PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAIN TERMINATOR 
aspirin, acetaminophen, caffeine, salicylamide tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69103-2507
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	162 mg
SALICYLAMIDE (UNII: EM8BM710ZC) (SALICYLAMIDE - UNII:EM8BM710ZC)	SALICYLAMIDE	152 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	110 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	blue (SKY BLUE)	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	FR2
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69103-2507-5	250 in 1 CARTON	04/03/2015
1		2 in 1 PACKET; Type 0: Not a Combination Product
2	NDC: 69103-2507-6	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	03/31/2015

Labeler - Provision Medical Products (036936831)

Registrant - Provision Medical Products (036936831)

Establishment
Name	Address	ID/FEI	Business Operations
Ultraseal Corporation		085752004	pack(69103-2507)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(69103-2507)