OTC Medication Information: ACETAMINOPHEN 325 MG

ACETAMINOPHEN 325 MG- acetaminophen tablet
Preferred Pharmaceuticals 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.

Drug Facts

Active ingredient (in each tablet)

Acetaminophen USP, 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 or menstrual cramps
temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
child takes more than 5 tablets in 24 hours, which is the maximum daily amount
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks while using this product

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

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
pain gets worse or lasts more than 5 days in children
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. 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 4-6 hours while symptoms last, not more than 12 tablets in 24 hours

children 6 to 11 years

take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours

children under 6 years

do not use

Other information

store at 15° to 30°C (59° to 86°F)

Inactive ingredients

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

Questions or comments?

call 516-341-0666, 8:30 am — 4:30 pm ET, Monday — Friday

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

*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.

Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580

www.reliable1labs.com

Repackaged By: Preferred Pharmaceuticals Inc.

NDC 68788-7245

Regular Strength

Acetaminophen USP 325 mg

PAIN RELIEVER

FEVER REDUCER

*Compare to Active Ingredient in Regular Strength TYLENOL®

Acetaminophen Tablets 325mg
(click image for full-size original)
ACETAMINOPHEN 325 MG
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7245(NDC:69618-010)
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
STARCH, CORN
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
POVIDONE, UNSPECIFIED
Product Characteristics
Color white Score no score
Shape ROUND Size 8mm
Flavor Imprint Code AP;012
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7245-3 30 TABLET in 1 BOTTLE, PLASTIC None
2 NDC:68788-7245-6 60 TABLET in 1 BOTTLE, PLASTIC None
3 NDC:68788-7245-9 90 TABLET in 1 BOTTLE, PLASTIC None
4 NDC:68788-7245-1 100 TABLET in 1 BOTTLE, PLASTIC None
Image of Product
(click image for full-size original)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 08/16/2018
Labeler — Preferred Pharmaceuticals Inc. (791119022)
Registrant — Preferred Pharmaceuticals Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals Inc. 791119022 REPACK (68788-7245)

Revised: 05/2019 Preferred Pharmaceuticals Inc.

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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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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