PAIN RELIEF EXTRA STRENGTH- acetaminophen 500mg capsule, coated

Pain Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredient(s)

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Use(s)

temporarily relieves minor aches and pains due to:

• the common cold
• headache
• backache 
• minor pain of arthritis
• toothache
• muscular aches
• premenstrual and menstrual cramps
• temporarily reduces fever

Warnings

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

• more than 4,000mg 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.

•  if you are allergic to acetaminophen or any of the inactive ingredients in this product
  

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 symptoms occur
• redness or swelling is present. These could be signs of a serious
  condition

Pregnancy/Breastfeeding

ask a health professional before use.

Keep out of reach of children

Overdose warning: In case of overdose, get medical 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 take 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*, hypromellose, polyethylene glycol, povidone, pregelatinized starch,
purified water*, sodium starch glycolate, stearic acid, titanium dioxide*
*may contain these ingredients

Questions

Call 1-888-952-0050 Monday to Friday 9am-5pm EST

Principal Display Panel

Pain Relief

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH
acetaminophen 500mg capsule, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-426
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
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
POVIDONE K30 (UNII: U725QWY32X)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
May contain	STARCH, CORN (UNII: O8232NY3SJ)
May contain	TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
May contain	WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score	no score
Shape	CAPSULE	Size	18mm
Flavor		Imprint Code	G551
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-426-05	500 in 1 BOTTLE; Type 0: Not a Combination Product	05/17/2021
2	NDC: 69168-426-40	1 in 1 CARTON	08/05/2021
2		40 in 1 BOTTLE; Type 0: Not a Combination Product
3	NDC: 69168-426-24	1 in 1 CARTON	12/15/2021
3		24 in 1 BOTTLE; Type 0: Not a Combination Product
4	NDC: 69168-426-32	100 in 1 BOTTLE; Type 0: Not a Combination Product	06/06/2022

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

Labeler - Allegiant Health (079501930)