Regular Strength Pain Relief by St. Mary's Medical Park Pharmacy gc 102

Regular Strength Pain Relief by

Drug Labeling and Warnings

Regular Strength Pain Relief by is a Otc medication manufactured, distributed, or labeled by St. Mary's Medical Park Pharmacy. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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gc 102

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.

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Inactive Ingredients
Ingredient Name	Strength
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	GC101
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60760-453-50	50 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/15/2021	01/31/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	03/15/2021	01/31/2023

Labeler - St. Mary's Medical Park Pharmacy (063050751)

Establishment
Name	Address	ID/FEI	Business Operations
St. Mary's Medical Park Pharmacy		063050751	relabel(60760-453) , repack(60760-453)

Revised: 12/2024

Document Id: 291a1416-ecd8-dc95-e063-6394a90aabe7

34390-5

Set id: bd46f985-43df-40f9-e053-2a95a90ada9f

Version: 3

Effective Time: 20241212