ACETA-GESIC description, usages, side effects, indications, overdosage, supplying and lots more!

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ACETA-GESIC

Rugby Laboratories
Time Cap Labs, Inc.




FULL PRESCRIBING INFORMATION

Do not use

  • WITH ANY OTHER DRUG CONTAINING ACETAMINOPHEN(PRESCRIPTION OR NONPRESCRIPTION). IF YOU ARE NOT SURE WHETHER A DRUG CONTAINS ACETAMINOPHEN, ASK A DOCTOR OR PHARMACIST.

Ask a doctor before use if you have liver disease.

Ask a doctor or pharmacist before use if you are

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Stop use and ask a doctor if

pain persists for more than 10 days; fever persists for more than 3 days (unless directed by a doctor); condition worsens or new symptoms appear; redness or swelling is present. These could be signs of a serious condition.

If pregnant or nursing, as with any drug, seek the advise of a heath professional before using this product.

Keep this and all drugs out of reach of children

Directions
adults and children 12 years and over: take 1 to 2 tablets every six hours while symptoms last. Maximum daily dose is 9 tablets in 24 hours unless directed by a doctor.

children under 12 years: Do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

Other information

  • store at 25° C (77° F) excursions permitted between 15°-30° C (59°-86° F)
  • use by expiration date on package
  • avoid excessive heat
  • sodium free

colloidal silicon dioxide, crospovidone, fd&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, pregelatinized starch, stearic acid

Uses

Uses: temporarily relieves minor aches and pains due to:

headache, backache, muscular aches, arthritis pain, colds, flu, fever, toothache, premenstrual cramps.

Purpose

Pain Reliever-fever reducer-antihistamine

Warnings:

Liver warning: This product contains acetaminophen. Severe liver damage may occur if: adult or child 12 years and older takes more than 12 tablets in 24 hours, which is the maximum daily amount; taking with other drugs containing acetaminophen; adult has 3 or more alcoholic drinks every day while using this product.

Active ingredient

Each tablet contains:

acetaminophen 325 mg

diphenhydramine HCl 12.5 mg

ACETA-GESIC

ACETA-GESIC

ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE TABLET, COATED

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-1003
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 325 mg
DIPHENHYDRAMINE HYDROCHLORIDE DIPHENHYDRAMINE 12.5 mg

Inactive Ingredients

Ingredient Name Strength
COLLOIDAL SILICON DIOXIDE
CROSPOVIDONE
FD&C YELLOW NO. 6
HYPROMELLOSES
MAGNESIUM STEARATE
cellulose, microcrystalline
povidone
STARCH, PREGELATINIZED CORN
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
orange 11 mm TCL106 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-1003-01 100 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2014-01-13


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