Acetaminophen Oral Suspension 160 Mg Per 5 Ml (grape Flavor)

SPL v2

SPL

SPL Set ID 3f88de0f-6cf6-3580-e063-6294a90abcb4

Route

ORAL

Published

Effective Date 2025-09-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Glycerin Water Sorbitol Solution 70% Fd&c Red No. 40 Sucrose Xanthan Gum Sucralose Anhydrous Citric Acid Fd&c Blue No. 1 Sodium Benzoate

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-09-22

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

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

Section 34088-5

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

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 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.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Section 51945-4

OneSsip Acetaminophen 160 mg per 5 mL Cherry Flavor Oral Suspension

Free of:

Dyes
Alcohol
Ibuprofen
Aspirin
Parabens
High Fructose Corn Syrup

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

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.

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.

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
Follow the instruction given on this carton for your easy use.

Age (Years)	Dose (mL)*
under 2 years	ask a doctor
2 to under 6	1 Sachet (5 mL)
6 to 11 years	2 Sachet (10 mL)

*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.

mL = mililiter

Other Information

store between 20-25°C (68-77°F)
do not use if carton or sachet is torn, broken or punctured.

Inactive Ingredients

anhydrous citric acid, FD&C Red No. 40, FD&C Blue 1, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

Questions Or Comments?

call 1-516-675-8915

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Structured Label Content

Uses

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

Section 34088-5 (34088-5)

Overdose warning

In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

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 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.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Section 51945-4 (51945-4)

OneSsip Acetaminophen 160 mg per 5 mL Cherry Flavor Oral Suspension

Free of:

Dyes
Alcohol
Ibuprofen
Aspirin
Parabens
High Fructose Corn Syrup

Purpose

Pain reliever/fever reducer

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

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.

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.

Directions

this product does not contain directions or complete warnings for adult use.
do not give more than directed (see overdose warning)
Follow the instruction given on this carton for your easy use.

Age (Years)	Dose (mL)*
under 2 years	ask a doctor
2 to under 6	1 Sachet (5 mL)
6 to 11 years	2 Sachet (10 mL)

*dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor.

mL = mililiter

Other Information (Other information)

store between 20-25°C (68-77°F)
do not use if carton or sachet is torn, broken or punctured.

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, FD&C Red No. 40, FD&C Blue 1, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum

Questions Or Comments? (Questions or comments?)

call 1-516-675-8915

Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))

Acetaminophen 160 mg

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily reduces fever Temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache", "34088-5": "Overdose warning In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)", "50565-1": "Keep out of reach of children.", "50566-9": "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.", "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", "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. if your child is allergic to acetaminophen or any of the inactive ingredients in this product", "51945-4": "OneSsip Acetaminophen 160 mg per 5 mL Cherry Flavor Oral Suspension Free of: Dyes Alcohol Ibuprofen Aspirin Parabens High Fructose Corn Syrup", "Purpose": "Pain reliever/fever reducer", "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 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. 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.", "Directions": "this product does not contain directions or complete warnings for adult use. do not give more than directed (see overdose warning ) Follow the instruction given on this carton for your easy use. Age (Years) Dose (mL)* under 2 years ask a doctor 2 to under 6 1 Sachet (5 mL) 6 to 11 years 2 Sachet (10 mL) *dose may be repeated every 4 hours while symptoms persist, upto five times a day or as directed by a doctor. mL = mililiter", "Other information": "store between 20-25°C (68-77°F) do not use if carton or sachet is torn, broken or punctured.", "Inactive ingredients": "anhydrous citric acid, FD&C Red No. 40, FD&C Blue 1, flavors, glycerin, purified water, sodium benzoate, sorbitol solution, sucralose, sucrose, xanthan gum", "Questions or comments?": "call 1-516-675-8915", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:05.774341 · Updated: 2026-03-14T23:13:35.542610