Skip to Content

← See all Acetaminophen brands

Acetaminophen by FFREDS, INC

Medically reviewed on Jul 14, 2017

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg
Labeler: FFREDS, INC
NDC Code: 55315-987

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

EXTRA STRENGTH
PAIN RELIEVER
ACETAMINOPHEN, USP 500 mg

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
■ the common cold
■ toothache
■ premenstrual and menstrual cramps
■ temporarily reduces fever

Liver warning

This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (3,000 mg) in 24 hours. 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 reaction. 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.

Overdose warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. 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 use for more than 10 days unless directed by a doctor
children under 12 years
ask a doctor

Other information

■ store between 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, black iron oxide irradiated, colloidal silicon dioxide, croscarmellose sodium, gelatin, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, hypromellose, iron oxide red, isopropyl alcohol, n-butyl alcohol, polyethylene glycol, povidone k-30, pregelatinized starch, propylene glycol, shellac glaze (modified), stearic acid, titanium dioxide, yellow iron oxide.

Questions or comments?

call 1-877-770-3183 Mon-Fri 9:00 AM to 4:30 PM EST

EXTRA STRENGTH
PAIN RELIEVER
ACETAMINOPHEN, USP 500 mg

Pain Reliever/Fever Reducer
24 GELCAPS
500 mg each

ACETAMINOPHEN 
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-987
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, PREGELATINIZED CORN 
PROPYLENE GLYCOL 
AMMONIA 
SILICON DIOXIDE 
GELATIN 
FERRIC OXIDE RED 
ISOPROPYL ALCOHOL 
BUTYL ALCOHOL 
POLYETHYLENE GLYCOLS 
POVIDONE K30 
HYPROMELLOSES 
FERROSOFERRIC OXIDE 
CROSCARMELLOSE SODIUM 
HYDROXYPROPYL CELLULOSE, UNSPECIFIED 
SHELLAC 
STEARIC ACID 
TITANIUM DIOXIDE 
FERRIC OXIDE YELLOW 
Product Characteristics
Colorgray (one red opaqe and one blue-gray hard gelatin shells) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint CodeG1
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-987-2424 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/17/2017
Labeler - FFREDS, INC (005866116)

 
FFREDS, INC

← See all Acetaminophen brands

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide