Drug Facts

Drug Facts

SPL v2

SPL

SPL Set ID e37b5492-fd4b-438e-88ba-e524740b7a62

Route

ORAL

Published

Effective Date 2018-05-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Butylparaben Carboxymethylcellulose Sodium Powdered Cellulose Citric Acid Monohydrate Fd&c Red No. 40 Corn Syrup Glycerin Propylene Glycol Sodium Benzoate Xanthan Gum Saccharin Sodium Sorbitol Water

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 1999-03-16

Description

Acetaminophen 160 mg

Purpose

Pain reliever/Fever reducer

Medication Information

Purpose

Pain reliever/Fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- immunizations
- toothache

Section 50565-1

Keep out of reach of children.

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

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.
if needed, repeat dose every 4 hours
do not use more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor
only use enclosed measuring cup

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24-35	2-3	1 tsp or 5 mL
36-47	4-5	1½ tsp or 7.5 mL
48-59	6-8	2 tsp or 10 mL
60-71	9-10	2½ tsp or 12.5 mL
72-95	11	3 tsp or 15 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

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.

Other Information

•
Store at room temperature 15º - 30ºC (59º - 86ºF)
•
Protect from Freezing.
•
Protect from Light.
•
each teaspoon (5 mL) contains: sodium 3 mg
•
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

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

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red # 40, flavor, glycerin, propylene glycol, water, sodium benzoate, sorbitol, xanthan gum, Sodium saccharin.

Principal Display Panel

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.

Active Ingredient (in Each 5 Ml = 1 Teaspoon)

Acetaminophen 160 mg

Structured Label Content

Uses

temporarily:

reduces fever
relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- immunizations
- toothache

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Purpose

Pain reliever/Fever reducer

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.
if needed, repeat dose every 4 hours
do not use more than 5 times in 24 hours
do not give more than 5 days unless directed by a doctor
only use enclosed measuring cup

Weight (lbs.)	Age (yrs.)	Dose (tsp or mL)
under 24	under 2	ask a doctor
24-35	2-3	1 tsp or 5 mL
36-47	4-5	1½ tsp or 7.5 mL
48-59	6-8	2 tsp or 10 mL
60-71	9-10	2½ tsp or 12.5 mL
72-95	11	3 tsp or 15 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

Overdose Warning (Overdose warning)

Other Information (Other information)

•
Store at room temperature 15º - 30ºC (59º - 86ºF)
•
Protect from Freezing.
•
Protect from Light.
•
each teaspoon (5 mL) contains: sodium 3 mg
•
TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING

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)

butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red # 40, flavor, glycerin, propylene glycol, water, sodium benzoate, sorbitol, xanthan gum, Sodium saccharin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Stop Use and Ask A Doctor If (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.

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

Acetaminophen 160 mg

Advanced Ingredient Data

[{"name": "acetaminophen", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "BUTYLPARABEN", "unii": "3QPI1U3FV8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POWDERED CELLULOSE", "unii": "SMD1X3XO9M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CORN SYRUP", "unii": "9G5L16BK6N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "XANTHAN GUM", "unii": "TTV12P4NEE", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily: reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat immunizations toothache", "50565-1": "Keep out of reach of children.", "50567-7": "When using this product do not exceed recommended dose (see overdose warning )", "50568-5": "Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin", "50569-3": "Ask a doctor before use if your child has liver disease", "Purpose": "Pain reliever/Fever reducer", "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. if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours do not give more than 5 days unless directed by a doctor only use enclosed measuring cup Weight (lbs.) Age (yrs.) Dose (tsp or mL) under 24 under 2 ask a doctor 24-35 2-3 1 tsp or 5 mL 36-47 4-5 1½ tsp or 7.5 mL 48-59 6-8 2 tsp or 10 mL 60-71 9-10 2½ tsp or 12.5 mL 72-95 11 3 tsp or 15 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", "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.", "Other information": "• Store at room temperature 15º - 30ºC (59º - 86ºF) • Protect from Freezing. • Protect from Light. • each teaspoon (5 mL) contains: sodium 3 mg • TAMPER EVIDENT: DO NOT USE THIS PRODUCT IF PRINTED INNER CAP SEAL IS BROKEN OR MISSING", "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": "butylparaben, carboxymethylcellulose sodium, cellulose, citric acid, corn syrup, FD&C red # 40, flavor, glycerin, propylene glycol, water, sodium benzoate, sorbitol, xanthan gum, Sodium saccharin.", "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.", "Active ingredient (in each 5 mL = 1 teaspoon)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:33.719940 · Updated: 2026-03-14T22:55:06.338046