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pain relief by Publix Super Markets Inc

Medically reviewed on June 13, 2018

Dosage form: capsule, liquid filled
Ingredients: ACETAMINOPHEN 325mg
Labeler: Publix Super Markets Inc
NDC Code: 56062-005

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.

Publix Super Markets, Inc. Pain Relief Drug Facts

Active ingredient (in each capsule)

Acetaminophen 325 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

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if

adult takes more than 4,000 mg of acetaminophen 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 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 the user
has liver disease
is a child with pain of arthritis

Ask a doctor or pharmacist before use if the user is

taking the blood thinning drug warfarin

Stop use and ask a doctor if
pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
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 capsules every 4 to 6 hours while symptoms last
do not take more than 10 capsules in 24 hours
do not use for more than 10 days unless directed by a doctor

children 6-11 years

take 1 capsule every 4 to 6 hours while symptoms last
do not take more than 5 capsules in 24 hours
do not use for more than 5 days unless directed by a doctor

children under

6 years

ask a doctor

Other information
store at 20-25°C (68-77°F)

Inactive ingredients

edible ink*, FD&C red no. 40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution *may contain this ingredient

Package/Label Principal Display Panel

REGULAR STRENGTH

pain relief

ACETAMINOPHEN 325 mg

PAIN RELIEVER

FEVER REDUCER

ACTUAL SIZE

90 LIQUID GELS**

**Liquid-Filled Capsules

Compare to the Active Ingredient in Regular Strength Tylenol®

PAIN RELIEF 
acetaminophen capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56062-005
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
FD&C RED NO. 40 
GELATIN 
GLYCERIN 
POLYETHYLENE GLYCOLS 
POVIDONES 
PROPYLENE GLYCOL 
WATER 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize16mm
FlavorImprint CodeA325
Contains    
Packaging
#Item CodePackage Description
1NDC:56062-005-751 BOTTLE in 1 CARTON
190 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34305/03/2016
Labeler - Publix Super Markets Inc (006922009)

 
Publix Super Markets Inc

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Further information

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

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