Your browser does not support JavaScript! PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) CAPSULE, COATED [PUBLIX SUPER MARKETS INC]
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PAIN RELIEF EXTRA STRENGTH (acetaminophen) capsule, coated
[Publix Super Markets Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each caplet)

Acetaminophen 500 mg

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

Warnings

Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 caplets (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

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 reach of children.

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 Liver 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 at 20º-25ºC (68º-77ºF)

Inactive ingredients

hypromellose, polyethylene glycol, povidone, pregelatinized starch, sodium starch glycolate, stearic acid

Principal Display Panel

EXTRA STRENGTH

painrelief

ACETAMINOPHEN 500mg

PAIN RELIEVER/FEVER REDUCER

easy to swallow caplets

for adults

ACTUAL SIZE

Compare to Active Ingredient in Extra Strength Tylenol® Caplets

Pain Relief Carton Image 1
Pain Relief Carton Image 2
PAIN RELIEF  EXTRA STRENGTH
acetaminophen capsule, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:56062-917
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSES 
POLYETHYLENE GLYCOLS 
POVIDONES 
STEARIC ACID 
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULESize16mm
FlavorImprint Code L917
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56062-917-711 in 1 CARTON
150 in 1 BOTTLE
2NDC:56062-917-781 in 1 CARTON
2100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34301/31/2011
Labeler - Publix Super Markets Inc (006922009)
Registrant - L. Perrigo Company (006013346)

Revised: 2/2013
 
Publix Super Markets Inc

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