328 - Pain Relief Extra Strength

Pain Relief by

Drug Labeling and Warnings

Pain Relief by is a Otc medication manufactured, distributed, or labeled by Good Sense. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAIN RELIEF EXTRA STRENGTH- acetaminophen 500 mg tablet 
Good Sense

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328 - Pain Relief Extra Strength

Active ingredient(s)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Use(s)

temporary relief of minor aches and pains associated with   ■ common cold   ■ headache    ■  toothache   ■ muscular aches   ■ backache     ■ arthritis    ■ menstrual cramps    ■ and reduction of fever

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4000 mg of acetaminophen in 24 hours, which is the maximum daily amount 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

• if you are allergic to acetaminophen  
• 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

liver disease

Ask a doctor or pharmacist before use if

are taking the blood thinning drug warfarin

Stop use and ask a doctor if

• symptoms do not improve pain gets worse or lasts for more than 10 days 
• fever gets worse or lasts for more than 3 days new symptoms occur redness or swelling is present 
• a rare sensitivity reaction occurs   
• You may report side effects to 1-888-952-0050

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

In case of accidental overdose, contact a doctor or Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Do not exceed recommended dosage.

Overdose Warning

 Overdose Warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get help or contact a Poison Control Center (1-800-222-1222) 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 use more than directed (see overdose warning)  

■ adults and children 12 years and over:  take 2 caplets every 6 hours while symptoms last ■ do not take more than 8 caplets in 24 hours, unless directed by
a doctor ■ do not take for more than 10 days unless directed by a doctor.  

■ children under 12 years: ask a doctor 

Other information

  ■ do not use if imprinted safety seal under cap is broken or missing

Storage

■ store between 20º-25ºC (68º-77ºF)

Inactive ingredients

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

Principal Display Panel

Pain Relief

PAIN RELIEF  EXTRA STRENGTH
acetaminophen 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50804-328
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)	Â
STEARIC ACID (UNII: 4ELV7Z65AP)	Â
POVIDONE (UNII: FZ989GH94E)	Â
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)	Â

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	17mm
Flavor		Imprint Code	AZ328
Contains	   Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50804-328-01	1 in 1 CARTON	04/28/2021	11/30/2025
1		100 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	12/17/2014	11/30/2025

Labeler - Good Sense (076059836)

Revised: 4/2021

Document Id: 570321ec-6b67-4a37-ba51-26c5055896ee

34390-5

Set id: 3168ccdc-bcd1-43fe-9781-07991191e96b

Version: 5

Effective Time: 20210428

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