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 (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:

• 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: 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

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

• adults and children 12 years and over: two (2) caplets every 6 hours with a full glass of water with each dose. Do not exceed; adults 8 caplets and children 6 caplets in 24 hours .
• children under 12 years of age: consult a doctor

Other information

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

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)