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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN 250 MG, ASPIRIN 250 MG (nsaid*), CAFFEINE 65 MG * NONSTEROIDAL ANIT-INFLAMMATORY DRUG
Available from:
AvPAK
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
PAIN RELIEVER - PAIN RELIEVER AID 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.
Authorization status:
OTC monograph not final
Authorization number:
50268-053-11, 50268-053-15

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

AvPAK

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.

----------

Acetaminophen, Aspirin (NSAID) and Caffeine

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

EXTRA PAIN RELIEF

acetaminophen, aspirin and caffeine tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:50 26 8 -0 53(NDC:49 48 3-370 )

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AvPAK

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

250 mg

ASPIRIN (UNII: R16 CO5Y76 E) (ASPIRIN - UNII:R16 CO5Y76 E)

ASPIRIN

250 mg

CAFFEINE (UNII: 3G6 A5W338 E) (CAFFEINE - UNII:3G6 A5W338 E)

CAFFEINE

6 5 mg

Inactive Ingredients

Ingredient Name

Stre ng th

CARNAUBA WAX (UNII: R12CBM0 EIZ)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

CELLULO SE, MICRO CRYSTALLINE (UNII: OP1R32D6 1U)

MINERAL O IL (UNII: T5L8 T28 FGP)

PO VIDO NE (UNII: FZ9 8 9 GH9 4E)

STARCH, PREGELATINIZED CO RN (UNII: O8 232NY3SJ)

SO DIUM STARCH GLYCO LATE TYPE A CO RN (UNII: AG9 B6 5PV6 B)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Product Characteristics

Color

white

S core

no sco re

S hap e

CAPSULE (CAPSULE SHAPED TABLET)

S iz e

18 mm

Flavor

Imprint Code

TCL370

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:50 26 8 -0 53-15

50 in 1 BOX, UNIT-DOSE

0 8 /23/20 16

1

NDC:50 26 8 -0 53-11

1 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt343

0 8 /23/20 16

Labeler -

AvPAK (832926666)

Revised: 2/2018

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