PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
Medicine Shoppe International Inc

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.

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Medicine Shoppe International, Inc. Pain Relief Drug Facts

Active ingredient (in each caplet)

Acetaminophen 500 mg

Purpose

Pain reliever/fever reducer

Uses

temporarily relieves minor aches and pains due to:

•
headache
•
muscular aches
•
backache
•
arthritis
•
the common cold
•
toothache
•
menstrual cramps
•
reduces fever

Warnings

Overdose warning: Taking more than the recommended dose can cause serious health problems, including liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Do not use

•
with any other product containing acetaminophen

Stop use and ask a doctor if

•
redness or swelling is present
•
new symptoms occur
•
fever gets worse or lasts for more than 3 days
•
pain gets worse or lasts for more than 10 days

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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

Directions

•
do not use more than directed (see overdose warning)
•
adults and children 12 years and over: take 2 caplets every 6 hours as needed
•
do not take more than 8 caplets in 24 hours
•
children under 12 years: do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems

Other information

•
store at room temperature (59º-86ºF)

Inactive ingredients

carnauba wax*, croscarmellose sodium*, hypromellose, polyethylene glycol, povidone, sodium metabisulfite*, sodium starch glycolate*, starch, stearic acid *may contain one or more of these ingredients

Principal Display Panel

EXTRA STRENGTH CAPLETS

PAIN RELIEF

Non Aspirin - Acetaminophen

Pain Reliever/Fever Reducer

COMPARE TO EXTRA STRENGTH TYLENOL® active ingredient

500 mg EACH

Pain Relief Carton Image 1

Pain Relief Carton Image 1

Pain Relief Carton Image 2

Pain Relief Carton Image 1

Pain Relief Carton Image 2

PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49614-123
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX (UNII: R12CBM0EIZ)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49614-123-781 in 1 CARTON07/15/198706/10/2013
1100 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:49614-123-711 in 1 CARTON07/15/198706/10/2013
250 in 1 BOTTLE; Type 0: Not a Combination Product
3NDC:49614-123-90500 in 1 BOTTLE; Type 0: Not a Combination Product07/15/198706/10/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/15/198706/10/2013
Labeler - Medicine Shoppe International Inc (071997654)

Revised: 11/2017
Document Id: d753dc1e-8879-4d88-b27a-5292dc1e6c99
Set id: 67dadaa3-3794-4629-9806-493fb0250404
Version: 2
Effective Time: 20171125
 
Medicine Shoppe International Inc