EXTRA PAIN RELIEF- acetaminophen, aspirin and caffeine tablet, film coated

EXTRA PAIN RELIEF by

Drug Labeling and Warnings

EXTRA PAIN RELIEF by is a Otc medication manufactured, distributed, or labeled by Apace Packaging, LLC, Time Cap Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

ACETAMINOPHEN 250 MG

ASPIRIN 250 MG (nsaid*)

CAFFEINE 65 MG
* NONSTEROIDAL ANIT-INFLAMMATORY DRUG

INACTIVE INGREDIENTS

Carnauba Wax, Colloidal Silicon Dioxide, Hypromellose, Microcrystalline Cellulose, Mineral Oil, Povidone, Pregelatinized Starch, Sodium Starch Gylolate, Stearic Acid, Titanium Dioxide

PURPOSE

PAIN RELIEVER - PAIN RELIEVER AID

DIRECTIOINS

DO NOT USE MORE THAN DIRECTED - DRINK A FULL GLASS OF WATER WITH EACH DOSE - ADULTS AND CHILDREN 12 YEARS AND OVER TAKE 2 TABLETS EVERY 6 HOURS, NOT MORE THAN 8 TABLETS IN 24 HOURS .

USES

TEMPORARILY RELIEVES MINOR ACHES AND PAINS DUE TO: headache - a cold - arthritis - muscular aches - toothache - premenstrual and menstrual cramps

DO NOT USE

Do not use if you have ever had an allergic reaction to acetaminophe, aspirin or any other pain reliever/fever reducer; with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

WARNINGS

REYE'S SYNDROME:

Children and teenages who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an eary sign of Reye's syndrome, a rare but serious illnes.

ALLERY ALERT

Aspirin may cause a severe allergic reaction which may include:

hives

facial swelling

asthma (sheezing)

shock

LIVER WARNING:

This product contains acetaminophen. Severe liver damage may occur if you take

more than 8 tablets in 24 hours, which is the maximum daily amount;

with other drugs containing acetaminophen;

3 or more alcoholic drinks every day while usng this product

STOMACH BLEEDING WARNING:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

are age 60 or older;

have had stomach ulcers or bleeding problems

take a blood thinning (anticogulant) or steroid drug

take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen,naproxen, or others)

take more or for a longer time than directed

CAFFEINE WARNING:

The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine containing medications, foods or beverages which while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness and occasionally, rapid heart beat.

KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any sighs or symptoms

PREGNANCY

If Pregnant or breast-feeding ask a helth professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor becausde it may cause prombles inthe unborn child or complications during delivery.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose

5026805315

NDC 50268-053-15
EXTRA PAIN RELIEF
Acetaminophen, Aspirin (NSAID) and Caffeine
EXTRA STREGTH
50 Tablets (5 X 10) Unit Dose

5026805315

INGREDIENTS AND APPEARANCE

EXTRA PAIN RELIEF 
acetaminophen, aspirin and caffeine tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 15338-703(NDC:49483-370)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)	CAFFEINE	65 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MINERAL OIL (UNII: T5L8T28FGP)
POVIDONE (UNII: FZ989GH94E)
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE (CAPSULE SHAPED TABLET)	Size	18mm
Flavor		Imprint Code	TCL370
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 15338-703-05	50 in 1 BOX, UNIT-DOSE	08/23/2016
1	NDC: 15338-703-11	1 in 1 BLISTER PACK; 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	08/23/2016

Labeler - Apace Packaging, LLC (361961142)

Establishment
Name	Address	ID/FEI	Business Operations
Time Cap Laboratories, Inc.		037052099	manufacture(15338-703)

Establishment
Name	Address	ID/FEI	Business Operations
Apace Packaging, LLC		361961142	repack(15338-703) , label(15338-703)