ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
PHARMACY VALUE ALLIANCE, LLC

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Arthitis Pain
Acetaminophen
Extended-release Tablets USP, 650 mg

Pain Reliever / Fever Reducer
For Temporary Relef of Minor Arthritis Pain
Contains No Aspirin

Active ingredient

(in each caplet)
Acetaminophen USP, 650 mg

Purpose

Pain reliever/fever reducer

Uses
(For Muscle Aches & Pain)

■ temporarily relieves minor aches and pains due to:
■ muscular aches
■ backache

■ minor pain of arthritis

■ toothache
■ premenstrual and menstrual cramps

■ headache
■ the common cold

■ temporarily reduces fever

Uses
(For Arthritis Pain)

■ 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

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 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.

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 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
(For Muscle Aches & Pain)

■ do not take more than directed (see overdose warning)

adults and children 12 years of age and over

■ 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

children under 12 years of age

■ do not use

Directions
(For Arthritis Pain)

■ d o 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

■ store between 20-25°C (68-77°F)

do not use if foil inner seal is broken or missing

Inactive ingredients

hydroxy ethyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid.

Questions or comments?

Contact 1-877-770-3183 Mon-Fri 8:00 AM EST to 5:00 PM PST.

For Muscle Aches & Pain

50ct

For Arthritis Pain

50 ct100ct

ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-183
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 (4000 MPA.S AT 1%) (UNII: ZYD53NBL45)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (White to off white colored) Scoreno score
ShapeOVAL (Capsule shaped, biconvex intact film coated tablets) Size19mm
FlavorImprint Code G;650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-183-0550 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
2NDC:68016-183-10100 in 1 BOTTLE; Type 0: Not a Combination Product11/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154411/15/2019
Labeler - PHARMACY VALUE ALLIANCE, LLC (101668460)

Revised: 12/2020
Document Id: b7b4bf85-8a0e-4b0f-e053-2a95a90abf05
Set id: 8fb0762d-da96-7b54-e053-2995a90a03fe
Version: 2
Effective Time: 20201230
 
PHARMACY VALUE ALLIANCE, LLC