PAIN RELIEF- pain relief tablet, extended release 
Allegiant Health

----------

461 - Pain Relief

Active ingredient(s)

Acetaminophen USP,  650 mg

Purpose

Pain reliever/fever reducer

Use(s)


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

Warnings

Liver warning: This product contains acetaminophen. Severe Liver damage may occur if you take
• more than 6 caplets in 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday 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 drugs 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

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.

If pregnant or 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 right away.(1-800 222-1222).  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

•take 2 caplets every 8 hours with water
•swallow whole; do not crush, chew, split or dissolve
•do not take more than 6 caplets in 24 hours
•do not use for more than 10 days unless directed by a doctor

Under 18 years of age: ask a doctor


Other information

Inactive ingredients

hydroxyethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Questions/Comments

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

Principal Display Panel

Pain Relief

Pain Relief

PAIN RELIEF 
pain relief tablet, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-461
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-461-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
2NDC:69168-461-03250 in 1 BOTTLE; Type 0: Not a Combination Product05/24/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154404/24/2024
Labeler - Allegiant Health (079501930)

Revised: 4/2024
Document Id: c12eb153-1ae0-4096-8e92-ca1021322605
Set id: f4720346-c3e0-4707-b007-1bf1f5e05707
Version: 1
Effective Time: 20240424
 
Allegiant Health