ACETAMINOPHEN CAPLETS, 500 MG  EXTRA STRENGTH- acetaminophen tablet 
GRAXCELL PHARMACEUTICAL, 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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Acetaminophen Caplets, 500 mg, 70795-1200

Active ingredient (in each tablet)

ACETAMINOPHEN 500 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 you take

Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:

If a skin reaction occurs, stop use and seek medical help right away.

Do not use:

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

These could be signs of a serious condition.

If pregnant or breast-feeding, ask a health professional before use.

Do not use

without consulting a physician

Ask a physician before use

 if you have a sodium restricted diet due to multiple organ diseases

Stop use and ask a physician

If symptoms of heat cramps continue for more than 24 hours

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

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

Adults and children 12 years and over

Children under 12 years

Other information

INACTIVE INGREDIENTS

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

01b LBL_Acetominaphen_500mg_front

01b LBL_Acetominaphen_500mg_back

ACETAMINOPHEN CAPLETS, 500 MG   EXTRA STRENGTH
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70795-1200
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)  
HYPROMELLOSE 2208 (100000 MPA.S) (UNII: VM7F0B23ZI)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
POVIDONE (UNII: FZ989GH94E)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVALSize18mm
FlavorImprint Code 500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70795-1200-1100 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
2NDC:70795-1200-2200 in 1 BOTTLE; Type 0: Not a Combination Product11/16/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34311/16/2020
Labeler - GRAXCELL PHARMACEUTICAL, LLC (056556923)

Revised: 12/2021
Document Id: d3adeaa9-0a44-7e46-e053-2995a90a9419
Set id: 4982c78e-3813-4ca8-aaa3-f6679eb72f9f
Version: 4
Effective Time: 20211221
 
GRAXCELL PHARMACEUTICAL, LLC