ACETAMINOPHEN- acetaminophen tablet 
LEADER/ Cardinal Health 110, Inc

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8HR Arthritis Pain Relief
Acetaminophen Extended-Release Tablets USP 650mg
Pain Reliever/Fever Reducer

Active ingredient ​(in each caplet)

Acetaminophen USP, 650 mg

Purpose


Pain reliever/ fever reducer

Uses

Liver warning:

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

Allergy alert:


acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use

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

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

do not take more than directed (see overdose warning)

adults


under 18 years of age

Other information

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.

PDP

APAP 650mg 225ctAPAP 650mg 100ctAPAP 650mg 50ct

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0627
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
POVIDONE K30 (UNII: U725QWY32X)  
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize19mm
FlavorImprint Code G650
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0627-150 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
2NDC:70000-0627-2100 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
3NDC:70000-0627-3225 in 1 BOTTLE; Type 0: Not a Combination Product03/23/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21154403/23/2023
Labeler - LEADER/ Cardinal Health 110, Inc (063997360)

Revised: 12/2023
Document Id: 0c5647a1-cff4-7fb0-e063-6394a90a2efe
Set id: f797848e-f23f-997b-e053-6394a90aae55
Version: 4
Effective Time: 20231212
 
LEADER/ Cardinal Health 110, Inc