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
- do not take more than directed (see overdose warning)
adults and children 12 years and over |
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children 6-11 years |
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children under 6 years |
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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.
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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.