fd5918a5-a0b1-482e-95d5-0837b2ebc44f
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Active Ingredient Acetaminophen 160 mg
Medication Information
Warnings and Precautions
Warnings
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
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.
Indications and Usage
Uses
temporarily reduces fever
temporarily relieves minor aches and pains due to:
• the common cold • flu • headache
• sore throat • toothache
Dosage and Administration
Directions
• this product does not contain directions or
complete warnings for adult use.
• shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use
with this product. Do not use any other dosing
device.
• if needed, repeat dose every 4 hours while
symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed
by a doctor
Weight (lb)
Age (yr)
Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 1 teaspoon or 5 mL
36-47 4-5 1 1/2 teaspoons or 7.5 mL
48-59 6-8 2 teaspoons or 10 mL
60-71 9-10 2 1/2 teaspoons or 12.5 mL
72-95 11 3 teaspoons or 15 mL
Description
Active Ingredient Acetaminophen 160 mg
Section 50565-1
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the
recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately. Quick medical attention is
critical even if you do not notice any signs or
symptoms.
Section 50566-9
Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Section 50567-7
When using this product
• do not exceed recommended dose
(see overdose warning)
Section 50568-5
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
Section 50569-3
Ask a doctor before use if your child has
liver disease.
Section 51727-6
Inactive Ingredients
acesulfame potassium, butyl paraben,
carboxymethylcellulose sodium, cellulose, citric acid,
flavors, glycerin, high fructose corn syrup, propylene
glycol, purified water, red 40, sodium benzoate,
sorbitol, xanthan gum
Section 51945-4
Section 55105-1
Purpose
Acetaminophen.............................Pain reliever/fever reducer
Section 55106-9
Active Ingredient
Acetaminophen 160 mg
Section 60561-8
Other information
• store at controlled room temperature
• see bottom panel for lot number and
expiration date
Structured Label Content
Indications and Usage (34067-9)
Uses
temporarily reduces fever
temporarily relieves minor aches and pains due to:
• the common cold • flu • headache
• sore throat • toothache
Dosage and Administration (34068-7)
Directions
• this product does not contain directions or
complete warnings for adult use.
• shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age.
• use only enclosed dosing cup designed for use
with this product. Do not use any other dosing
device.
• if needed, repeat dose every 4 hours while
symptoms last
• do not give more than 5 times in 24 hours
• do not give more than 5 days unless directed
by a doctor
Weight (lb)
Age (yr)
Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 1 teaspoon or 5 mL
36-47 4-5 1 1/2 teaspoons or 7.5 mL
48-59 6-8 2 teaspoons or 10 mL
60-71 9-10 2 1/2 teaspoons or 12.5 mL
72-95 11 3 teaspoons or 15 mL
Warnings and Precautions (34071-1)
Warnings
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
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.
Section 50565-1 (50565-1)
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the
recommended dose (overdose) may cause liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control
Center immediately. Quick medical attention is
critical even if you do not notice any signs or
symptoms.
Section 50566-9 (50566-9)
Stop use and ask a doctor if
• new symptoms occur
• redness or swelling is present
• pain gets worse or lasts more than 5 days
• fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Section 50567-7 (50567-7)
When using this product
• do not exceed recommended dose
(see overdose warning)
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if your child is
taking the blood thinning drug warfarin.
Section 50569-3 (50569-3)
Ask a doctor before use if your child has
liver disease.
Section 51727-6 (51727-6)
Inactive Ingredients
acesulfame potassium, butyl paraben,
carboxymethylcellulose sodium, cellulose, citric acid,
flavors, glycerin, high fructose corn syrup, propylene
glycol, purified water, red 40, sodium benzoate,
sorbitol, xanthan gum
Section 51945-4 (51945-4)
Section 55105-1 (55105-1)
Purpose
Acetaminophen.............................Pain reliever/fever reducer
Section 55106-9 (55106-9)
Active Ingredient
Acetaminophen 160 mg
Section 60561-8 (60561-8)
Other information
• store at controlled room temperature
• see bottom panel for lot number and
expiration date
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T11:55:41.618963 · Updated: 2026-03-14T22:53:35.209708