DOLEX FORTE- acetaminophen, aspirin, caffeine tablet 
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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DOLEX® FORTE (AAA)

Drug Facts

Active Ingredients and Purpose

Active IngredientsPurposes
Acetaminophen 250 mg.................................Pain reliever
Aspirin 250 mg (NSAID*)................................Pain reliever
Caffeine 65 mg.................................................Pain reliever aid

* nonsteroidal anti-inflammatory drug

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps

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:

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

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • facial swelling
  • shock
  • asthma (wheezing)

Stomach bleeding warning:

This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:

  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

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, rapid heartbeat.

Do not use

  • if you have ever had an allergic reactionto 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

  • you have liver disease
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis, or kidney disease
  • you are taking a diuretic
  • you have asthma

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for:
  • diabetes
  • gout
  • arthritis
  • taking any other drug, or are under a doctor’s care for any serious condition

Stop use and ask a doctor if

  • an allergic reaction occurs. Seek medical help right away.
  • you experience any of the following signs of stomach bleeding:
    • feel faint
    • vomit blood
    • have bloody or black stools
    • have stomach pain that does not get better
  • pain gets worse or lasts for more than 10 days
  • redness or swelling is present
  • new symptoms occur
  • ringing in the ears or loss of hearing occurs

    These could be signs of a serious condition.

If pregnant or breast-feeding,

If pregnant or breast-feeding, 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 (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.

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).

Liver warning:

This product contains acetaminophen.
Severe liver damage may occur if you take

  • more than 8 caplets in 24 hours, which is the

maximum daily amount

  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this

product

Directions

  • do not use more than directed
  • drink a full glass of water with each dose
  • adults and children 12 years and over: take 4 to 8 tablets every 4 hours; do not exceed 48 tablets in 24 hours
  • children under 12 years: consult a doctor

Other information

  • store between 20°-25°C (68°-77°F) in a dry place
  • retain carton for complete product information

Inactive ingredients

carnauba wax, colloidal
silicon dioxide, hypromellose, microcrystalline
cellulose, mineral oil, povidone, pregelatinized starch,
sodium starch glycolate, stearic acid, titanium dioxide

Questions?

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

Principal Display Panel

DOLEX®

FORTE

EXTRA STRENGTH


Acetaminophen, Aspirin ,Caffeine

Pain reliever/Pain reliever Aid

24 Caplets

Dolex Fprte Box

DOLEX FORTE 
acetaminophen, aspirin, caffeine tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-019
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
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
MINERAL OIL (UNII: T5L8T28FGP)  
POVIDONE (UNII: FZ989GH94E)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ)  
Product Characteristics
ColorwhiteScorescore with uneven pieces
ShapeCAPSULE ((Capsule-Shaped Tablet)) Size19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55758-019-241 in 1 CARTON03/25/201304/01/2023
124 in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/25/201304/01/2023
Labeler - Pharmadel LLC (030129680)

Revised: 4/2023
 
Pharmadel LLC