ACETAMINOPHEN- acetaminophen tablet, film coated, extended release 
Kroger Company

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Kroger Co. Acetaminophen Drug Facts

Active ingredient (in each caplet)

Acetaminophen 650 mg

Purpose

Pain reliever/fever reducer

Uses

•
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

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 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.

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 and children 12 years 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
•
do not use

Other information

•
store at 20-25°C (68-77°F)
•
meets the requirements of USP Dissolution Test 2

Inactive ingredients

carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

1-800-632-6900

Package/Label Principal Display Panel

COMPARE TO the active ingredient of TYLENOL® 8HR See inside panel

OUR PHARMACIST RECOMMENDED

8 Hour Pain Relief

actual size

Acetaminophen Extended-Release Tablets, 650 mg

Pain Reliever/Fever Reducer

For up to 8 Hours Relief of Minor Muscle Aches & Pain

100 CAPLETS** 650 mg EACH

**capsule-shaped tablets

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

DO NOT USE IF PRINTED FOIL UNDER CAP IS BROKEN OR MISSING

acetaminophen image
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-119
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScoreno score
ShapeOVALSize19mm
FlavorImprint Code L544
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-119-78100 in 1 BOTTLE; Type 0: Not a Combination Product05/05/201712/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07507705/05/201712/31/2021
Labeler - Kroger Company (006999528)

Revised: 11/2022
Document Id: 5d341e4b-7330-4fdf-b747-e8ab349c2189
Set id: d16ec408-d77e-4a1e-b37d-06d019a16f01
Version: 3
Effective Time: 20221103
 
Kroger Company