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pain relief

Geiss, Destin & Dunn, Inc (Goodsense)

DRUG FACTS


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient (in each tablet)

Acetaminophen 500 mg

Purpose

Pain reliever/ fever reducer

pain relief Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • the common cold
    • backache 
    • minor arthritis pain 
    • toothache
    • muscular aches
    • premenstrual and menstrual cramps
    • temporarily reduces fever

Warnings

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 ever day while using this product

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

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Overdose warning: 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 signs or symptoms.

Directions

  • do not take more than directed (see overdose warning)
  • adults and children 12 years and over:
    • take 2 tablets every 4 to 6 hours while symptoms last.
    • Do not take more than 8 tablets in 24 hours
    • do not take for more than 10 days unless directed by a doctor
  • children under 12 years: do not use

pain relief Other information

  • store at controlled room temperature 15°-30°C (59°-86°F)

Inactive ingredients

povidone, pregelatinized starch, sodium starch glycolate*, stearic acid

*may contain this ingredient

Questions or comments?

Call 1-877-753-3935 Monday- Friday 9AM- 5PM EST

Principal Display Panel

†Compare to ACTIVE INGREDIENT in TYLENOL® Extra Strength

Extra Strength

PAIN RELIEF

pain reliever/ fever reducer

ACETAMINOPHEN 500 mg

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

†This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark Tylenol®

DISTRIBUTED BY:

GEISS, DESTIN & DUNN, Inc.,

Peachtree city, GA 30269

www.valuelabels.com

Product Label

pain relief
Acetaminophen 500 mg

pain relief

Acetaminophen TABLET

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50804-016
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 500 mg

Inactive Ingredients

Ingredient Name Strength
POVIDONES
STARCH, CORN
sodium starch glycolate type a corn
STEARIC ACID

Product Characteristics

Color Size Imprint Code Shape
WHITE 12 mm TCL;252 ROUND

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 100 in 1 BOTTLE, PLASTIC
2 NDC:50804-016-00 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part343 2011-11-15


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