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

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Drug Facts

ACTIVE INGREDIENT (IN EACH CAPLET)

Acetaminophen USP, 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). Avoid excessive heat 40° C (104° F).
see end panel for batch number and expiration date
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.

INACTIVE INGREDIENTS

Croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, propylene glycol, sodium lauryl sulfate, stearic acid, titanium dioxide

QUESTIONS?

Call 1-800-406-7984

PRINCIPAL DISPLAY PANEL - 24 Caplet Bottle Carton

Walgreens

Compare to Tylenol® 8 HR Muscle
Aches & Pain active ingredient††

NDC 0363-0336-24

8-Hour
Pain Reliever

ACETAMINOPHEN EXTENDED-RELEASE TABLETS USP,
650 mg / PAIN RELIEVER / FEVER REDUCER

MUSCLE PAIN
8 HOUR
CAPLETS

Relieves minor muscle pain for up to 8 hours

100
CAPLETS*
(*CAPSULE-SHAPED TABLETS)

ACTUAL SIZE

DO NOT USE WITH OTHER MEDICINES CONTAINING ACETAMINOPHEN

spl-apap-walgreens-100-caplet-bottle-carton
ACETAMINOPHEN 
acetaminophen tablet, film coated, extended release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0336
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN650 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule Shaped) Size19mm
FlavorImprint Code cor116
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-0336-01100 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
2NDC:0363-0336-2424 in 1 BOTTLE; Type 0: Not a Combination Product04/30/2002
3NDC:0363-0336-02200 in 1 BOTTLE; Type 0: Not a Combination Product06/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07620004/30/2002
Labeler - Walgreen Company (008965063)
Registrant - Sun Pharmaceutical Industries Inc. (146974886)
Establishment
NameAddressID/FEIBusiness Operations
Ohm Laboratories Inc.184769029MANUFACTURE(0363-0336)

Revised: 9/2019
Document Id: 6116df05-91b5-4f17-b6d7-bc5dcc693b21
Set id: 63be92a2-5093-4971-a193-4c1672350b1a
Version: 5
Effective Time: 20190904
 
Walgreen Company