OTC Medication Information: Regular Strength Pain Relief

REGULAR STRENGTH PAIN RELIEF- acetaminophen tablet
St. Mary’s Medical Park Pharmacy

Active Ingredients

Acetaminophen 325 mg

Purpose

Pain Reliever/Fever Reducer

Uses

  • temporarily relieves minor aches and pains
  • temporarily reduces fever

Warnings

Liver warning: This product contains acetaminophen.
The maximum daily dose of this product is 10 tablets
in 24 hours. Severe liver damage may occur if you take:

  • more than 12 tablets (4,000 mg of acetaminophen)

in 24 hours

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day 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 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 symptom 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. 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
  • adults and children 12 years and over: take 2 tablets every 4-6 hours, as needed; not more than 10 tablets in 24 hours
  • children under 12 years: ask a doctor

Other Information

  • store at 20⁰C-25⁰C (68⁰F-77⁰F)

Inactive Ingredients

povidone, sodium starch glycolate, starch stearic acid.

ACET
(click image for full-size original)

REGULAR STRENGTH PAIN RELIEF
acetaminophen tablet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:60760-453(NDC:57896-102)
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
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
STEARIC ACID
Product Characteristics
Color white Score no score
Shape ROUND Size 10mm
Flavor Imprint Code GC101
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:60760-453-50 50 TABLET in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M013 03/15/2021
Labeler — St. Mary’s Medical Park Pharmacy (063050751)
Establishment
Name Address ID/FEI Operations
St. Mary’s Medical Park Pharmacy 063050751 relabel (60760-453), repack (60760-453)

Revised: 12/2023 St. Mary’s Medical Park Pharmacy

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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