Llorens-apapsuschild 850

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Sucrose Sucralose Potassium Sorbate Xanthan Gum Glycerin Sodium Citrate Citric Acid Monohydrate Sorbitol Water Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-12-01

Medication Information

Indications and Usage

Uses

temporarily reduces fever
temporarilty relieves minor aches and pains due to:
headache
sore throat
the common cold
toothache

Purpose

Pain Reliever / Fever Reducer

Description

Acetaminophen 160 mg

Section 50565-1

Keep out of reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.

Section 50569-3

When using this product: Do not exceed recommended dose.

Ask a doctor before use if your child hasliver disease.

Section 51945-4

Directions

do not give more than directed
shake well before using
this product does not contain directions or complete warnings for adult use
find dose in chart below; if possible, use weight to dose, otherwise use age
dosage may be repeated every 4 hours, or as directed by a doctor
do not give more than 5 times 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)

Do Not Use

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Liver Warning

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen.

Allergy Alert:

acetaminophen may cause sever skin reactions. Symptoms may include

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Sore Throat Warning

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients

artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum

Questions? Comments?

Call 1-866-595-5598

Stop Use and Ask A Doctor If

pain gets worse or lasts more than 5 days
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.

Active Ingredient (in Each 5ml = 1 Teaspoon)

Acetaminophen 160 mg

Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily reduces fever
temporarilty relieves minor aches and pains due to:
headache
sore throat
the common cold
toothache

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if your child istaking the blood thinning drug warfarin.

Section 50569-3 (50569-3)

When using this product: Do not exceed recommended dose.

Ask a doctor before use if your child hasliver disease.

Section 51945-4 (51945-4)

Purpose

Pain Reliever / Fever Reducer

Directions

do not give more than directed
shake well before using
this product does not contain directions or complete warnings for adult use
find dose in chart below; if possible, use weight to dose, otherwise use age
dosage may be repeated every 4 hours, or as directed by a doctor
do not give more than 5 times 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)

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product.

Liver Warning (Liver warning)

This product contains acetaminophen. Severe liver damage may occur if your child takes

more than 5 doses in 24 hours, which is the maximum daily amount
with other drugs containing acetaminophen.

Allergy Alert:

acetaminophen may cause sever skin reactions. Symptoms may include

skin reddening
blisters
rash

If a skin reaction occurs, stop use and seek medical help right away.

Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.

Sore Throat Warning (Sore throat warning)

if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Inactive Ingredients (Inactive ingredients)

artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum

Questions? Comments? (QUESTIONS? COMMENTS?)

Call 1-866-595-5598

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

pain gets worse or lasts more than 5 days
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.

Active Ingredient (in Each 5ml = 1 Teaspoon) (Active ingredient (in each 5mL = 1 teaspoon))

Acetaminophen 160 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily reduces fever temporarilty relieves minor aches and pains due to: headache sore throat the common cold toothache", "50565-1": "Keep out of reach of children.", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.", "50569-3": "When using this product: Do not exceed recommended dose. Ask a doctor before use if your child has liver disease.", "Purpose": "Pain Reliever / Fever Reducer", "Directions": "do not give more than directed shake well before using this product does not contain directions or complete warnings for adult use find dose in chart below; if possible, use weight to dose, otherwise use age dosage may be repeated every 4 hours, or as directed by a doctor do not give more than 5 times 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)", "Do not use": "with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.", "Liver warning": "This product contains acetaminophen. Severe liver damage may occur if your child takes more than 5 doses in 24 hours, which is the maximum daily amount with other drugs containing acetaminophen. Allergy Alert: acetaminophen may cause sever skin reactions. Symptoms may include skin reddening blisters rash If a skin reaction occurs, stop use and seek medical help right away.", "Overdose warning": "Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical even if you do not notice any signs or symptoms.", "Sore throat warning": "if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Inactive ingredients": "artifical and natural grap flavor, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose, sodium, potassium sorbate, purified water, sorbitol solution, sucralose, and xanthan gum", "QUESTIONS? COMMENTS?": "Call 1-866-595-5598", "Stop use and ask a doctor if": "pain gets worse or lasts more than 5 days 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.", "Active ingredient (in each 5mL = 1 teaspoon)": "Acetaminophen 160 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information