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

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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Acetaminophen, Aspirin (NSAID) and Caffeine (Product contract packaged by Apace Packaging, LLC)

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

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 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.

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

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

label 1
label 2
label 3
EXTRA PAIN RELIEF 
acetaminophen, aspirin and caffeine tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15338-703(NDC:49483-370)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScoreno score
ShapeCAPSULE (CAPSULE SHAPED TABLET) Size18mm
FlavorImprint Code TCL370
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:15338-703-0550 in 1 BOX, UNIT-DOSE08/23/2016
1NDC:15338-703-111 in 1 BLISTER PACK; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/23/2016
Labeler - Apace Packaging, LLC (361961142)
Establishment
NameAddressID/FEIBusiness Operations
Time Cap Laboratories, Inc.037052099manufacture(15338-703)
Establishment
NameAddressID/FEIBusiness Operations
Apace Packaging, LLC361961142repack(15338-703) , label(15338-703)

Revised: 11/2018
Document Id: 7a9269a4-c0bf-9a93-e053-2991aa0a3c48
Set id: 7a92a39a-5c6e-483b-e053-2991aa0abc2a
Version: 2
Effective Time: 20181113
 
Apace Packaging, LLC