DOLEX ACETAMINOPHEN 500MG EXTRA STRENGTH- acetaminophen capsule, coated 
Pharmadel 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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Rapidol Acetaminophen 500 (HPharma)

Drug Facts

Active ingredient & Purpose

Active ingredient (in each caplet)Purpose
Acetaminophen 500 mgPain reliever/ fever reducer

Uses

For the temporary relief of minor aches and pains due to:

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:

■ 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 allergic to of the inactive ingredients in this product

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
  • redness or swelling is present
  • any new symptoms occur

These could be signs of a serious condition.

If pregnant or breast feeding,

Keep out of reach of children.

Keep out of reach of children.

Overdose warning:

In case of an accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

AgeDose
adults and children 12 years of age 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 of age
  • consult a doctor

Other information

Inactive ingredients

corn starch,hypromellose,magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone k90, stearic acid, titanium dioxide

Distributed by:

PHARMADEL LLC.

New Castle, DE 19720

1-866-359-3478

Prinicipal Display Panel

Rapidol PDP

DOLEX ACETAMINOPHEN 500MG  EXTRA STRENGTH
acetaminophen capsule, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-372
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
MAGNESIUM CITRATE (UNII: RHO26O1T9V)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
Product Characteristics
ColorwhiteScoreno score
ShapeOVAL (Capsule-Shaped Tablet) Size18mm
FlavorImprint Code AP500
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-372-241 in 1 CARTON04/07/2023
124 in 1 BOTTLE; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34304/07/2023
Labeler - Pharmadel LLC (030129680)

Revised: 4/2023
Document Id: f8c383c1-d1b6-ceaa-e053-6294a90a6053
Set id: f8c383c1-d1b7-ceaa-e053-6294a90a6053
Version: 1
Effective Time: 20230407
 
Pharmadel LLC