acetaminophen oral solution usp, 160 mg/5 ml

SPL v2

SPL

SPL Set ID 319ede76-110e-4902-a931-39a6d3b8c731

Route

oral

Published

Effective Date 2024-10-17

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 polyethylene glycol, unspecified water sodium benzoate trisodium citrate dihydrate saccharin sodium sorbitol glycerin

Identifiers & Packaging

Pill Appearance

Color: red

Marketing Status

otc monograph drug active Since 2023-08-10

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Medication Information

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
arthritis
the common cold
toothache
menstrual cramps
reduces fever

Purpose

Pain reliever/fever reducer

Directions

Do not exceed recommended dosage.

Other Information

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive Ingredients

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

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.

for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Section 53414-9

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

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.

Active Ingredient

Acetaminophen, USP 160 mg

Questions Or Comments?

1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued:08/2023

Ask A Doctor Before Use

if you have health issues especially liver disease.

Stop Use and Ask A Doctor If

new symptoms occur such as rash, hives, itching or hoarseness
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
symptoms do not improve

These could be signs of a serious condition.

Ask A Doctor Or Pharmacist Before Use

if you are taking other drugs, including the blood thinner warfarin.

Principal Display Panel 473 Ml Bottle Label

NDC 57237-304-16

Acetaminophen Oral Solution USP

160 mg/5 mL

Pain Reliever

Fever Reducer

Sugar Free

Alcohol Free

Aspirin Free

Cherry Flavor

16 fl. oz. (473 mL)

Structured Label Content

Uses

temporarily relieves minor aches and pains due to:

headache
muscular aches
backache
arthritis
the common cold
toothache
menstrual cramps
reduces fever

Purpose

Pain reliever/fever reducer

Directions

Do not exceed recommended dosage.

Other Information (Other information)

If dispensed, dispense in a tight, light resistant container with a child-resistant cap.

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)

Inactive Ingredients (Inactive ingredients)

Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Section 50570-1 (50570-1)

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.

for more than 10 days for pain unless directed by a doctor
for more than 3 days for fever unless directed by a doctor
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

Section 53414-9 (53414-9)

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

Allergy Alert (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.

Active Ingredient (Active ingredient )

Acetaminophen, USP 160 mg

Questions Or Comments? (Questions or comments?)

1-844-474-7464

Distributed by:

Rising Pharma Holdings, Inc.

East Brunswick, NJ 08816

Issued:08/2023

Ask A Doctor Before Use (Ask a doctor before use)

if you have health issues especially liver disease.

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

new symptoms occur such as rash, hives, itching or hoarseness
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
symptoms do not improve

These could be signs of a serious condition.

Ask A Doctor Or Pharmacist Before Use (Ask a doctor or pharmacist before use)

if you are taking other drugs, including the blood thinner warfarin.

Principal Display Panel 473 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label)

NDC 57237-304-16

Acetaminophen Oral Solution USP

160 mg/5 mL

Pain Reliever

Fever Reducer

Sugar Free

Alcohol Free

Aspirin Free

Cherry Flavor

16 fl. oz. (473 mL)

Advanced Ingredient Data

[{"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "160", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL, UNSPECIFIED", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRISODIUM CITRATE DIHYDRATE", "unii": "B22547B95K", "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": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves minor aches and pains due to: headache muscular aches backache arthritis the common cold toothache menstrual cramps reduces fever", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical even if you do not notice any signs or symptoms.", "50570-1": "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. for more than 10 days for pain unless directed by a doctor for more than 3 days for fever unless directed by a doctor if you are allergic to acetaminophen or any of the inactive ingredients in this product.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Pain reliever/fever reducer", "Directions": "Do not exceed recommended dosage.", "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.", "Other information": "If dispensed, dispense in a tight, light resistant container with a child-resistant cap. Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F)", "Active ingredient ": "Acetaminophen, USP 160 mg", "Inactive ingredients": "Cherry Flavor, Citric Acid, FD&C Red No. 40, Glycerin, Polyethylene Glycol, Purified Water, Sodium Benzoate, Sodium Citrate Dihydrate, Sodium Saccharin, Sorbitol.", "Questions or comments?": "1-844-474-7464 Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Issued:08/2023", "Ask a doctor before use": "if you have health issues especially liver disease.", "Stop use and ask a doctor if": "new symptoms occur such as rash, hives, itching or hoarseness redness or swelling is present pain gets worse or lasts for more than 10 days fever gets worse or lasts for more than 3 days symptoms do not improve These could be signs of a serious condition.", "Ask a doctor or pharmacist before use": "if you are taking other drugs, including the blood thinner warfarin.", "PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label": "NDC 57237-304-16 Acetaminophen Oral Solution USP 160 mg/5 mL Pain Reliever Fever Reducer Sugar Free Alcohol Free Aspirin Free Cherry Flavor 16 fl. oz. (473 mL)"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:03:52.565420 · Updated: 2026-03-14T23:04:10.666734