DOLEX FORTE- acetaminophen, aspirin, caffeine tablet 
Pharmadel LLC

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Dolex Forte (HPHARMA)

Drug Facts

Drug Facts

Active ingredients and Purposes

Active ingredientsPurposes
Acetaminophen 250 mg...................Pain reliever
Aspirin (NSAID*) 250 mg ................ Pain reliever
Caffeine 65 mg.................................Pain reliever aid/ diuretic

* nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

Warnings

Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin (NSAID) may cause a severe allergic reaction which may include:

Liver warning: This product contains Acetaminophen. Severe liver damage may occur if

Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if the user:

Caffeine warning: The recommended dose of this product contains about as much caffeine as a cup of coffee. Limit the use of caffeine-containing medications, foods, or beverages while taking this product because too much caffeine may cause nervousness, irritability, sleeplessness, and occasionally a rapid heartbeat.

Do not use

  • if the user has ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user

  • has liver disease
  • has a history of stomach problems, such as heartburn
  • has high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • takes a diuretic
  • has not been drinking fluids
  • has lost a lot of fluid due to vomiting or diarrhea
  • is a child with pain of arthritis
  • has asthma

Ask a doctor before use if

  • a stomach bleeding warning applies to user

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • users experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • has bloody or black stools
    • has stomach pain that does not get better
  • ringing in the ears or loss of hearing occurs
  • taking a prescription drug for diabetes, gout, or arthritis
  • adult's pain gets worse or lasts for more than 10 days
  • child's pain gets worse or lasts for more than 5 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling is present
  • new symptoms occur

If pregnant or breastfeeding,

ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of 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

Other information

Inactive ingredients

corn starch, crospovidone, hypromellose, microcrystalline cellulose, povidone, propylene glycol, sodium lauryl sulfate, sodium starch glycolate, stearic acid, titanium dioxide

Questions?

1-866-359-3478 (M-F) 9AM to 5PM EST or www.pharmadel.com

Distributed by / Distribuido por:

PHARMADEL LLC

New Castle, DE, 19720

Principal Display Panel

PDP DFORTE

DOLEX FORTE 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-306
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN250 mg
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN250 mg
CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE65 mg
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CROSPOVIDONE (UNII: 2S7830E561)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, CORN (UNII: O8232NY3SJ)  
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULE ((Capsule-Shaped Tablet)) Size18mm
FlavorImprint Code S53
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-306-241 in 1 CARTON04/10/2023
124 in 1 BOTTLE; Type 0: Not a Combination Product
2NDC:55758-306-5025 in 1 BOX04/25/202310/19/2023
2NDC:55758-306-022 in 1 PACKET; Type 0: Not a Combination Product
3NDC:55758-306-9950 in 1 CARTON10/19/2023
3NDC:55758-306-022 in 1 PACKET; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01303/24/2013
Labeler - Pharmadel LLC (030129680)

Revised: 10/2023
Document Id: 088bacc1-0192-4745-e063-6394a90a67c0
Set id: f9012cfa-9184-ec4c-e053-6294a90a6810
Version: 5
Effective Time: 20231025
 
Pharmadel LLC