ACETAMINOPHEN- acetaminophen tablet 
WALGREEN CO.

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Rapid Release Gelcaps
EXTRA STRENGTH
Acetaminophen Gelcaps USP, 500 mg
Pain reliever; Fever reducer
Aspirin free

Active ingredient (in each Gelcap)

Acetaminophen, USP 500 mg

Purpose

​Pain reliever/fever reducer

Uses

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

Liver warning:

This product contains acetaminophen. Severe liver damage may occur if you take:
■ more than 4,000 mg of acetaminophen in 24 hours
■ 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 have ever had an allergic reaction to this product or any of its ingredients

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 the reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Overdose warning

In case of accidental overdose, get medical help or contact a Poison Control Centerright 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 gelcaps every 6 hours while symptoms last
■ do not take more than 6 gelcaps in 24 hours, unless directed by a doctor
■ do not take more than 10 days unless directed by a doctor

children under 12 years
■ ask a doctor

Other information

■ store at 20°-25°C (68°-77°F). See USP Controlled Room Temperature

■ avoid high humidity
■ see end panel for lot number and expiration date

Inactive Ingredients

ammonium hydroxide, black iron oxide, colloidal silicon dioxide, croscarmellose sodium, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone, pregelatinized starch, propylene glycol, shellac glaze, stearic acid, titanium dioxide, yellow iron Oxide.

Questions or comments ?

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

PDP

375 ct225 ct150 ct50ct carton100ct carton24ct carton

ACETAMINOPHEN 
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9798
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)  
SHELLAC (UNII: 46N107B71O)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
BUTYL ALCOHOL (UNII: 8PJ61P6TS3)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
AMMONIA (UNII: 5138Q19F1X)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Product Characteristics
Colorgray (Encapsulated with red opaque and blue gray opaque hard gelatin shells) Scorescore with uneven pieces
ShapeOVALSize19mm
FlavorImprint Code G1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9798-2424 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
2NDC:0363-9798-0550 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
3NDC:0363-9798-15150 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2022
4NDC:0363-9798-21225 in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
5NDC:0363-9798-37375 in 1 BOTTLE; Type 0: Not a Combination Product06/25/2022
6NDC:0363-9798-10100 in 1 BOTTLE; Type 0: Not a Combination Product09/24/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01309/24/2021
Labeler - WALGREEN CO. (008965063)

Revised: 1/2024
Document Id: 0dfdddac-8e49-e297-e063-6394a90adbad
Set id: b375de90-25c7-aa55-e053-2995a90a3cf8
Version: 9
Effective Time: 20240102
 
WALGREEN CO.