Llorens- Liquid Acetaminophen 809

Llorens- Liquid Acetaminophen 809
SPL v6
SPL
SPL Set ID a7dbd4c0-53eb-4368-917b-1432c09ce6b4
Route
ORAL
Published
Effective Date 2022-07-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Methylparaben Polyethylene Glycol, Unspecified Propylene Glycol Propylparaben Water Sodium Citrate Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-10-01
Description

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

Medication Information

Warnings and Precautions

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

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.

Do not use 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.

Ask a doctor before use if you are taking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Indications and Usage

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Dosage and Administration

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
 Weight (lbs)  under 24  24-35  36-47 48-59   60-71  72-95  over 95
Age (years)   under 2  2 to 3  4 to 5  6 to 8  9 to 10  11  12 to adult
Dosage Teaspoonful (tsp)   consult Physician  1 tsp (5 mL)  1 1/2 tsp (7.5 mL)  2 tsp (10 mL)  2 1/2 tsp (12.5 mL)  3 tsp (15 mL)  4 tsp (20 mL)

Description

Active ingredient (per 5 mL teaspoonful) Acetaminophen 160 mg

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53414-9

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

Section 55105-1

Purpose

Pain Reliever/Fever Reducer

Section 55106-9

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves minor aches and pains due to:
  • headache
  • muscular aches
  • backache
  • minor pain of arthritis
  • the common cold
  • toothache
  • premenstrual and menstrual cramps
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than directed
  • find dose in chart below
  • if possible, use weight to dose, otherwise use age
  • dosage may be repeasted every 4 hours, or as directed by a doctor
  • do not give more than 5 doses in 24 hours
 Weight (lbs)  under 24  24-35  36-47 48-59   60-71  72-95  over 95
Age (years)   under 2  2 to 3  4 to 5  6 to 8  9 to 10  11  12 to adult
Dosage Teaspoonful (tsp)   consult Physician  1 tsp (5 mL)  1 1/2 tsp (7.5 mL)  2 tsp (10 mL)  2 1/2 tsp (12.5 mL)  3 tsp (15 mL)  4 tsp (20 mL)

Warnings and Precautions (34071-1)

Warnings

Liver Warning: This product contains acetaminophen. Severe liver damage may occur if:

  • adult takes more than 6 doses in 24 hours, which is the maximum daily amount
  • child takes more than 5 doses in 24 hours, which is the maximum daily amount
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday while using this product

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.

Do not use 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.

Ask a doctor before use if you are taking the blood thinning drug warfarin.

When using this product: Do not exceed recommended dose.

Stop use and ask a doctor if

  • pain gets worse or lasts more than 10 days in adults
  • pain gets worse or lasts more than 5 days in children under 12 years
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • redness or swelling is present. These could be signs of a serious condition.
Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Paoison Control Center right away. Quick medical attention is critical for adults/children even if you do not notice any signs or symptoms.

Section 51727-6 (51727-6)

Inactive ingredients: artificial and natural cherry flavor, citric acid, FD&C Red #40, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain Reliever/Fever Reducer

Section 55106-9 (55106-9)

Active ingredient (per 5 mL teaspoonful)

Acetaminophen 160 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:01.327035 · Updated: 2026-03-14T23:12:08.624404