FULTON STREET MARKET PAIN RELIEF EXTRA STRENGTH- acetaminophen tablet 
Access Business Group LLC

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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Access Business Group LLC 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:
•
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 20-25ºC (68-77ºF)

Inactive ingredients

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

Questions or comments?

1-800-719-9260

Principal Display Panel

contains no aspirin

extra strength

pain relief

acetaminophen

pain reliever/fever reducer

500 mg EACH

See New Warnings & Directions

Pain Relief Carton Image 1
Pain Relief Carton Image 2
FULTON STREET MARKET PAIN RELIEF  EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10056-300
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)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
POVIDONES (UNII: FZ989GH94E)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorWHITEScoreno score
ShapeCAPSULE (caplet) Size16mm
FlavorImprint Code L484
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10056-300-851 in 1 CARTON07/21/200501/31/2015
1250 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:10056-300-90500 in 1 BOTTLE; Type 0: Not a Combination Product07/21/200501/31/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34307/21/200501/31/2015
Labeler - Access Business Group LLC (839830713)

Revised: 11/2017
Document Id: b635fc64-bb2c-43bb-9ebe-249b5d6cf046
Set id: 7ac9457b-582e-4d92-a75e-8f3d387cc55f
Version: 2
Effective Time: 20171106
 
Access Business Group LLC