EXTRA PAIN RELIEF description, usages, side effects, indications, overdosage, supplying and lots more!

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EXTRA PAIN RELIEF

TIME CAP LABS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

 

DIRECTIONS

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.

EXTRA PAIN RELIEF

EXTRA PAIN RELIEF

ACETAMINOPHEN, ASPIRIN AND CAFFEINE TABLET, FILM COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49483-370
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 250 mg
aspirin ASPIRIN 250 mg
CAFFEINE 65 mg

Inactive Ingredients

Ingredient Name Strength
carnauba wax
COLLOIDAL SILICON DIOXIDE
HYPROMELLOSES
cellulose, microcrystalline
Mineral Oil
povidone
STARCH, PREGELATINIZED CORN
sodium starch glycolate type a corn
STEARIC ACID
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
white 18 mm TCL370 capsule

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49483-370-01 100 in 1 BOTTLE, PLASTIC
2 NDC:49483-370-20 200 in 1 BOTTLE, PLASTIC
3 NDC:49483-370-00 100000 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2013-11-01


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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