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Name:Acetaminophen
Manufacturer:Goldline Laboratories, Inc.
Category:Over-the-counter (OTC) Marketed Drugs


ACETAMINOPHEN TABLETS USP 325 mg PAIN RELIEVER/FEVER REDUCER

ACETAMINOPHEN - acetaminophen tablet 
Goldline Laboratories, Inc.

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
TABLETS USP
325 mg
PAIN RELIEVER/FEVER REDUCER

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

to reduce fever and for the temporary relief of minor aches and pains due to

  • headache
  • backache
  • the common cold
  • premenstrual and menstrual cramps
  • muscular aches
  • minor pain of arthritis
  • toothache

Temporarily reduces fever.

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if

  • adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

Ask a doctor before use if the user has liver disease.

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 or pharmacist before use if the user is taking the blood thinning drug warfarin.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults and children
  • pain gets worse or lasts more than 5 days in children under 12 years
  • 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

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). 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.

adults and children 12 years and over
  • take 2 tablets every 4 to 6 hours while symptoms last
  • do not take more than 12 tablets in 24 hours
children 6 to 11 years
  • take 1 tablet every 4 to 6 hours while symptoms last
  • do not take more than 5 tablets in 24 hours
children under 6 years Do not use adult regular strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

Other information

  • TAMPER-EVIDENT: Each tablet is individually sealed. Do not use if blister is torn or broken.
  • store at controlled room temperature 15° - 30°C (59° - 86°F)
  • protect from moisture, heat and light

Inactive ingredients

povidone, starch, stearic acid

Questions?

call 1-888-838-2872, weekdays, 8 AM - 5 PM Eastern Time

This unit dose package is not child-resistant. If dispensed for outpatient use, a child-resistant container should be utilized.

Manufactured for:
GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
by: LNK International, Inc.
Hauppauge, NY 11788
0609REV 05 99-391

PRINCIPAL DISPLAY PANEL - 325 mg label

NDC 0182-8447-89

TAMPER-EVIDENT

ACETAMINOPHEN
TABLETS USP

325 mg

PAIN RELIEVER/FEVER REDUCER
See new warning information.

100 (10×10) unit-dose tablets

Goldline

Principal Display Panel - 325 mg label

PRINCIPAL DISPLAY PANEL - 325 mg blister

NDC 0182-8447-00

ACETAMINOPHEN TABLET USP 325 mg

Mfd. for: GOLDLINE LABORATORIES, INC.
Sellersville, PA 18960
0609REV

Lot: 00000000
Exp: 00/0000

PEEL

Principal Display Panel - 325 mg blister

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0182-8447
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (Acetaminophen) Acetaminophen 325 mg
Inactive Ingredients
Ingredient Name Strength
povidone  
stearic acid  
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND (Bisect with flat face and beveled edge) Size 10mm
Flavor Imprint Code 44;104
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0182-8447-89 10 BLISTER PACK ( BLISTER PACK) in 1 CARTON contains a BLISTER PACK (0182-8447-00)
1 NDC:0182-8447-00 10 TABLET ( TABLET) in 1 BLISTER PACK This package is contained within the CARTON (0182-8447-89)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part343 01/01/1993

Labeler - Goldline Laboratories, Inc. (032349292)

Revised: 09/2009 Goldline Laboratories, Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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