PAIN TERMINATOR 2 SEVERE- aspirin, acetaminophen, caffeine tablet

PAIN TERMINATOR 2 SEVERE by

Drug Labeling and Warnings

PAIN TERMINATOR 2 SEVERE by is a Otc medication manufactured, distributed, or labeled by Provision Medical Products, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Uses:

for temporary relief of mild to moderate pain

associated with headache.

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.

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

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

Inactive Ingredients:

cellulose, pharmaceutical glaze,

povidone, starch, stearic acid and talc

USP.

ACTIVE INGREDIENT

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

PURPOSE

PAIN RELIEVER, FEVER REDUCER WITH ADJUVANT

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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)