DOLEX FORTE- acetaminophen, aspirin, caffeine tablet

Dolex Forte by

Drug Labeling and Warnings

Dolex Forte by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Drug Facts

Active ingredients and Purposes

• Active ingredients: Purposes
• 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 and bloating

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.

Allergy alert: Aspirin may cause severe allergic reactions. Symptoms may include:

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

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

• more than 6 capletsin 24 hours, which is the maximum daily amount
• with other drugs containing acetaminophen
• 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 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 everyday 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 a rapid heartbeat.

Do not use

• if you have 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

• 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, or arthritis
• 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
• ringing in the ears or loss of hearing occurs
• redness or swelling is present
• pain gets worse or lasts for more than 10 days
• fever gets worse or lasts for more than 3 days
• any new symptoms occur.

These could be signs of a serious condition.

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

• do not take more than directed (See WARNINGS)
• adults and children 12 years of age and over: take two (2) caplets every 6 hours with a glass of water. Do not take more than 6 caplets in 24 hours. children under 12 years of age: consult a doctor

Other information

• store between 68°-77°F (20°-25°C)
• keep box for important information and read before using.

Inactive ingredients

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

Distributed by / Distribuido por:

Pharmadel LLC

New Castle, DE 19720

Questions? +1-866-359-3478

Made in India / Hecho en India

Principal Display Panel

INGREDIENTS AND APPEARANCE

DOLEX FORTE 
acetaminophen, aspirin, caffeine tablet

Product 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)