Dolex Forte (hhh Pharma)

Dolex Forte (hhh Pharma)
SPL v2
SPL
SPL Set ID 3c2d90fc-130d-476c-e063-6294a90a8c15
Route
ORAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Aspirin (65 mg) Caffeine
Inactive Ingredients
Polyethylene Glycol 400 Talc Starch, Corn Silicon Dioxide Povidone K30 Hypromellose, Unspecified Cellulose, Microcrystalline Stearic Acid Water

Identifiers & Packaging

Pill Appearance
Imprint: HH6 Shape: capsule Color: white Size: 17 mm
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-12

Description

.

Purpose

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Medication Information

Purpose

.

Description

.

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps and bloating
Section 55105-1
Active ingredients Purposes
Acetaminophen 250 mg................... Pain reliever
Aspirin 250 mg (NSAID*)................ Pain reliever
Caffeine 65 mg................................. Pain reliever aid

* nonsteroidal anti-inflammatory drug

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 (NSAID) 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 8 tablets in 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.

Directions
  • do not take more than directed (See WARNINGS)
  • adults and children 12 years of age and older:take two (2) tablets every 6 hours with a full glass of water. Do not take more than 8 tablets in 24 hours. children under 12 years of age:consult a doctor
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.
Drug Facts

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Dist. By/ Por:

Pharmadel LLC

New Castle, DE 19720

Questions? +1-866-359-3478

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength

Other Information
  • store between 68-77˚F (20-25˚C)
  • keep box for important information
  • read all product information before use
Inactive Ingredients

corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, water

Principal Display Panel

Ask A Doctor Before Use If
  • you have liver disease
  • you have asthma
  • 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
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 appear.

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 (1-800-222-1222). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients and Purposes

.

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

Structured Label Content

Uses

Temporarily relieves minor aches and pains due to:

  • headache
  • a cold
  • arthritis
  • muscular aches
  • toothache
  • premenstrual and menstrual cramps and bloating
Section 55105-1 (55105-1)
Active ingredients Purposes
Acetaminophen 250 mg................... Pain reliever
Aspirin 250 mg (NSAID*)................ Pain reliever
Caffeine 65 mg................................. Pain reliever aid

* nonsteroidal anti-inflammatory drug

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 (NSAID) 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 8 tablets in 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.

Directions
  • do not take more than directed (See WARNINGS)
  • adults and children 12 years of age and older:take two (2) tablets every 6 hours with a full glass of water. Do not take more than 8 tablets in 24 hours. children under 12 years of age:consult a doctor
Do Not Use (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.
Drug Facts

.

Dist. By/ Por: (Dist. by/ por:)

Pharmadel LLC

New Castle, DE 19720

Questions? +1-866-359-3478

**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Excedrin® Extra Strength

Other Information (Other information)
  • store between 68-77˚F (20-25˚C)
  • keep box for important information
  • read all product information before use
Inactive Ingredients (Inactive ingredients)

corn starch, hypromellose, microcrystalline cellulose, polyethylene glycol 400, povidone k30, silicon dioxide, stearic acid, talc, water

Principal Display Panel

Ask A Doctor Before Use If (Ask a doctor before use if)
  • you have liver disease
  • you have asthma
  • 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
Stop Use and Ask A Doctor If (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 appear.

These could be signs of a serious condition.

If Pregnant Or Breastfeeding, (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. (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). Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredients and Purposes (Active ingredients and Purposes)

.

Ask A Doctor Or Pharmacist Before Use If You Are Taking (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

Advanced Ingredient Data


Raw Label Data

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