Llorens-dologesic 001

Llorens-dologesic 001
SPL v8
SPL
SPL Set ID 974fc0d5-7a99-46fb-af38-b91240f728fa
Route
ORAL
Published
Effective Date 2024-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (500 mg) Dexbrompheniramine (1 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Hydroxypropyl Methylcellulose Magnesium Stearate Cellulose, Microcrystalline Polyethylene Glycol, Unspecified Sodium Starch Glycolate Type A Corn Titanium Dioxide Talc Tricalcium Phosphate Polyvinyl Alcohol Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: LLORENS Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-04-01

Description

(in each caplet) Acetaminophen 500 mg Dexbrompheniramine Maleate 1 mg

Purpose

Pain reliever/fever reducer antihistamine


Medication Information

Purpose

Pain reliever/fever reducer

antihistamine

Description

(in each caplet) Acetaminophen 500 mg Dexbrompheniramine Maleate 1 mg

Uses
  • For the temporary relief of minor aches and pains associated with
  • headache
  • muscular aches
  • backaches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps
  • temporarily reduces fever
  • itchy and watery eyes due to hay fever
Section 43683-2

Added "itchy and watery eyes due to hay fever" in Uses section

Section 50565-1

Keep out of reach of children

Section 51945-4

Section 53414-9

If you are pregnant or breast-feeding, ask a health professional before use.

Warnings

Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 8 capsules in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminphen
  • 3 or more alcoholic drinks every day while using this product
  • May cause drowsiness:: alcohol, sedatives and tranquilizers may increase the drowsiness effect.
  • Avoid alcoholic beverages while taking this product
  • Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor.
  • Use caution when driving motor vehicle or operating machinery

Do not use

  • with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in the product
  • for more than 10 days for pain, unless directed by a doctor
  • for more than 3 days for fever, unless directed by a doctor

Ask a doctor before use:

  • if you have liver disease
  • if you are taking the blood thinning drug warafin

Stop using this product and ask a doctor if:

  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • these could be signs of a serious condition
Directions

Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or 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

Do not exceed recommended dosage

 Age Dose
 adults and children 12 years of age and over Take 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor 
 children under 12 years of age  Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Inactive Ingredients

FD&C Red #40, FD&C Yellow #6, glycerin, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose,polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, tricalcium phosphate

Questions Or Comments

1-866-595-5598


Structured Label Content

Uses
  • For the temporary relief of minor aches and pains associated with
  • headache
  • muscular aches
  • backaches
  • minor arthritis pain
  • common cold
  • toothaches
  • menstrual cramps
  • temporarily reduces fever
  • itchy and watery eyes due to hay fever
Section 43683-2 (43683-2)

Added "itchy and watery eyes due to hay fever" in Uses section

Section 50565-1 (50565-1)

Keep out of reach of children

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If you are pregnant or breast-feeding, ask a health professional before use.

Purpose

Pain reliever/fever reducer

antihistamine

Warnings

Alcohol Warning: If you consumer 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.

Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take

  • more than 8 capsules in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminphen
  • 3 or more alcoholic drinks every day while using this product
  • May cause drowsiness:: alcohol, sedatives and tranquilizers may increase the drowsiness effect.
  • Avoid alcoholic beverages while taking this product
  • Do not take this product if you are taking sedatives or tranquilizers, without consulting your doctor.
  • Use caution when driving motor vehicle or operating machinery

Do not use

  • with any other drug containing acetaminphen (prescription or non-prescription). If you are not sure whether a drug contains acetaminphen ask a doctor or pharmacist
  • if you are allergic to acetaminophen or any of the inactive ingredients in the product
  • for more than 10 days for pain, unless directed by a doctor
  • for more than 3 days for fever, unless directed by a doctor

Ask a doctor before use:

  • if you have liver disease
  • if you are taking the blood thinning drug warafin

Stop using this product and ask a doctor if:

  • pain gets worse or last more than 10 days
  • fever gets worse or last more than 3 days
  • new symptoms occur
  • redness or swelling is present
  • these could be signs of a serious condition
Directions

Overdose Warning: Taking more than recommended dose (overdose), may cause liver damage. In case of accidental overdose, contact a physician or 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

Do not exceed recommended dosage

 Age Dose
 adults and children 12 years of age and over Take 2 caplets every 4-6 hours. Do not take more than 8 caplets in 24 hours, or as directed by a doctor 
 children under 12 years of age  Do not use in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminphen and could cause liver damage

Active Ingredients

(in each caplet)

Acetaminophen 500 mg

Dexbrompheniramine Maleate 1 mg

Inactive Ingredients (Inactive ingredients)

FD&C Red #40, FD&C Yellow #6, glycerin, hydrocypropyl methyl cellulose, magnesium stearate, microcrystaline cellulose,polyethylene glycol, polyvinyl alcohol, sodium starch glycolate, talc, titanium dioxide, tricalcium phosphate

Questions Or Comments (Questions or comments)

1-866-595-5598


Advanced Ingredient Data


Raw Label Data

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