PAIN RELIEF EXTRA STRENGTH- acetaminophen 500 mg tablet

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

Acetaminophen 500mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

• the common cold
• headache
• backache 
• minor pain of arthritis
• toothache
• muscular achespremenstrual 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

• You may report side effects to 1-888-952-0050

If pregnant or breast-feeding

If pregnant or breast-feeding, ask a health professional before use. 

Keep Out of Reach of Children

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 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

Inactive Ingredients

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

Package/Label Principal Display Panel

Pain Relief

INGREDIENTS AND APPEARANCE

PAIN RELIEF  EXTRA STRENGTH
acetaminophen 500 mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69168-328
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)
STEARIC ACID (UNII: 4ELV7Z65AP)
POVIDONE (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69168-328-01	100 in 1 CARTON; Type 0: Not a Combination Product	12/17/2014
2	NDC: 69168-328-03	250 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2014
3	NDC: 69168-328-13	175 in 1 BOTTLE; Type 0: Not a Combination Product	12/17/2014
4	NDC: 69168-328-40	40 in 1 CARTON; Type 0: Not a Combination Product	12/17/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part343	12/17/2014

Labeler - Allegiant Health (079501930)