OTC Medication Information: Acetaminophen

ACETAMINOPHEN- acetaminophen tablet, coated
Central Texas Community Health Centers

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.

Drug Facts

Active ingredient (in each tablet)

Acetaminophen 325 mg

Purpose

Pain reliever/fever reducer

Uses

  • temporarily relieves minor aches and pains due to:
    • headache
    • muscular aches
    • backache
    • minor pain of arthritis
    • the common cold
    • toothache
    • premenstrual and menstrual cramps
  • 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 every 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 the user has liver disease.

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 in children 12 years and over
  • 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

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 6-11 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 this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

Other information

  • store between 20°-25°C (68°-77°F)
  • retain carton for complete product information

Inactive ingredients

crospovidone, methylparaben, povidone, pregelatinized starch, propylparaben, sodium starch glycolate, stearic acid

Distributed By McKesson One Post Street, San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL — 325 MG Tablet Bottle Label

CommUnityCare Federally Qualified Health Centers

ACETAMINOPHEN
325MG #30 TABS

Date:

Name:
Dr.

TAKE AS DIRECTED.

123456

1/1/01

ACETAMINOPHEN 325mg #30 NDC 76413-301-30

Batch: 123456
Lot: 123456
Exp: 1/1/01
SUNMARK

Federal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.

Principal Display Panel -- 325 MG Tablet Bottle Label
(click image for full-size original)
ACETAMINOPHEN
acetaminophen tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-301(NDC:49348-973)
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
POVIDONES
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A CORN
STEARIC ACID
Product Characteristics
Color WHITE Score 2 pieces
Shape ROUND Size 10mm
Flavor Imprint Code M2A3;57344
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76413-301-30 30 TABLET, COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part343 12/13/2012
Labeler — Central Texas Community Health Centers (079674019)
Establishment
Name Address ID/FEI Operations
Central Texas Community Health Centers 079674019 REPACK (76413-301), RELABEL (76413-301)

Revised: 03/2016 Central Texas Community Health Centers

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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