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Acetaminophen by FREDS, INC

Medically reviewed on July 17, 2017

Dosage form: capsule
Ingredients: ACETAMINOPHEN 500mg
Labeler: FREDS, INC
NDC Code: 55315-989

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

Pain Reliever/Fever Reducer

Active ingredient

(in each Caplet)
Acetaminophen, USP 500 mg

Purpose

Pain reliever/fever reducer

Purpose

Pain reliever/fever reducer

Uses

■ temporarily relieves minor aches and pains due to:
■ the common cold
■ headache
■ backache
■ minor pain of arthritis
■ toothache
■ muscular aches
■ 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 are allergic to acetaminophen or any other 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 the 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 6 hours while symptoms last
■ do not take more than 6 caplets 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
■ See end panel for lot number and expiration date

Inactive ingredients

hydroxypropyl methyl cellulose, pregelatinized starch, povidone k-30, polyethylene glycol, stearic acid, sodium starch glycolate

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
100 CAPLETS**
** Capsule-Shaped Tablets
500 mg each

EXTRA STRENGTH
PAIN RELIEVER
ACETAMINOPHEN, USP 500 mg
Pain Reliever/Fever Reducer
500 CAPLETS
500 mg each

ACETAMINOPHEN 
acetaminophen capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-989
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
POLYETHYLENE GLYCOLS 
HYPROMELLOSES 
STARCH, PREGELATINIZED CORN 
POVIDONE K30 
STEARIC ACID 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize18mm
FlavorImprint CodeG551
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-989-10100 CAPSULE in 1 BOTTLE
2NDC:55315-989-50500 CAPSULE in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34308/17/2017
Labeler - FREDS, INC (005866116)

 
FREDS, 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.

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