Label: DOLEX FORTE- acetaminophen, aspirin, caffeine tablet
- NDC Code(s): 55758-306-02, 55758-306-24, 55758-306-50, 55758-306-99
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 25, 2023
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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:
- hives
- facial swelling
- asthma (wheezing)
- shock
Liver warning: This product contains Acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses in 24 hours, which is the maximum daily amount
- child takes more than 3 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks everyday while using this product
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:
- has had stomach ulcers or bleeding problems
- takes a blood thinning (anticoagulant) or steroid drug
- takes other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
- takes more or for a longer time than directed
- has 3 or more alcoholic drinks everyday while using this product
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
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
- Directions
- Other information
- Inactive ingredients
- Questions?
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INGREDIENTS AND APPEARANCE
DOLEX FORTE
acetaminophen, aspirin, caffeine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-306 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 250 mg CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E) CAFFEINE 65 mg Inactive Ingredients Ingredient Name Strength 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 Color white Score score with uneven pieces Shape CAPSULE ((Capsule-Shaped Tablet)) Size 18mm Flavor Imprint Code S53 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-306-24 1 in 1 CARTON 04/10/2023 1 24 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:55758-306-50 25 in 1 BOX 04/25/2023 10/19/2023 2 NDC:55758-306-02 2 in 1 PACKET; Type 0: Not a Combination Product 3 NDC:55758-306-99 50 in 1 CARTON 10/19/2023 3 NDC:55758-306-02 2 in 1 PACKET; Type 0: Not a Combination Product 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 03/24/2013 Labeler - Pharmadel LLC (030129680)
