Childrens Pain Relief Oral Suspension Dye-free Grape

SPL v6

SPL

SPL Set ID 5ee134b3-b8e9-4621-b0a1-a84d9867ccba

Route

ORAL

Published

Effective Date 2024-04-11

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Butylparaben Glycerin Carboxymethylcellulose Sodium Cellulose, Microcrystalline High Fructose Corn Syrup Water Sucralose Xanthan Gum Propylene Glycol Sodium Benzoate Sorbitol

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2014-12-12

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
- toothache

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:

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

Allergy alert: Acetaminophen may cause severeskin 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, or 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 dose
do not take more than directed (see Overdose warning)
shake well before using
mL = milliliter
use only the 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
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)*
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3	5 mL
36-47 lbs	4-5	7.5 mL
48 - 59 lbs	6-8	10 mL
60 - 71 lbs	9-10	12.5 mL
72 - 95 lbs	11 years	15 mL

*or as directed by a doctor

Do Not Use

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

Questions?

Call 800-824-1706 Monday - Friday 9am - 4 pm MST

Package Label

WINCO FOODS Children's Pain Relief Dye Free Grape Flavor

Other Information

each 5 mL contains: sodium 2 mg
store between 20-25^oC(68-77^oF)
do not refrigerate
see bottom panel for lot number and expiration date

Inactive Ingredients

butylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid,flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol,sucralose, xanthan gum

Principal Display Panel

**Compare to the active ingredient in Children's TYLENOL® Oral Suspension

ORAL SUSPENSION

Pain Relief

Children's

ACETAMINOPHEN 160 mg per 5 mL /

PAIN RELIEVER - FEVER REDUCER

Alcohol Free

Aspirin & Inuprofen Free

For Ages 2-11 Years

Dye Free

Grape Flavor

FL OZ (mL)

**This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION.

DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704

Comments or Question?

800-824-1706 www.wincofoods.com

When Using This Product

do not exceed recommended dose (see overdose warning)

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
redness or swelling is present
new symptoms occur
These could be signs of a serious condition.

Keep Out of Reach of Children.

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 for adults as well as for children even if you do not notice any signs or symptoms.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is

taking the blood thinning drug warfarin

Structured Label Content

Uses

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

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes:

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

Allergy alert: Acetaminophen may cause severeskin 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, or 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 dose
do not take more than directed (see Overdose warning)
shake well before using
mL = milliliter
use only the 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
find the right dose on chart below. If possible, use weight to dose; otherwise, use age.

Weight (lb)	Age (year)	Dose (mL)*
under 24 lbs	under 2 years	ask a doctor
24-35 lbs	2-3	5 mL
36-47 lbs	4-5	7.5 mL
48 - 59 lbs	6-8	10 mL
60 - 71 lbs	9-10	12.5 mL
72 - 95 lbs	11 years	15 mL

*or as directed by a doctor

Do Not Use (Do not use)

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

Questions?

Call 800-824-1706 Monday - Friday 9am - 4 pm MST

Package Label (Package label)

WINCO FOODS Children's Pain Relief Dye Free Grape Flavor

Other Information (Other information)

each 5 mL contains: sodium 2 mg
store between 20-25^oC(68-77^oF)
do not refrigerate
see bottom panel for lot number and expiration date

Inactive Ingredients (Inactive ingredients)

Principal Display Panel

**Compare to the active ingredient in Children's TYLENOL® Oral Suspension

ORAL SUSPENSION

Pain Relief

Children's

ACETAMINOPHEN 160 mg per 5 mL /

PAIN RELIEVER - FEVER REDUCER

Alcohol Free

Aspirin & Inuprofen Free

For Ages 2-11 Years

Dye Free

Grape Flavor

FL OZ (mL)

**This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION.

DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704

Comments or Question?

800-824-1706 www.wincofoods.com

When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

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
redness or swelling is present
new symptoms occur
These could be signs of a serious condition.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Acetaminophen 160 mg

Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)

liver disease

Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)

taking the blood thinning drug warfarin

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "temporarily reduces fever relieves minor aches and pains due to: the common cold flu headache sore throat toothache", "Purpose": "Pain reliever/fever reducer", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if the child takes: more than 5 doses in 24 hours, which is maximum daily amount with other drugs containing acetaminophen Allergy alert: Acetaminophen may cause severeskin 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, or 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 dose do not take more than directed (see Overdose warning) shake well before using mL = milliliter use only the 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 find the right dose on chart below. If possible, use weight to dose; otherwise, use age. Weight (lb) Age (year) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 5 mL 36-47 lbs 4-5 7.5 mL 48 - 59 lbs 6-8 10 mL 60 - 71 lbs 9-10 12.5 mL 72 - 95 lbs 11 years 15 mL *or as directed by a doctor", "Do not use": "with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contain acetaminophen, ask a doctor or pharmacist drugs. if your child is allergic to acetaminophen or any of the inactive ingredients in this product.", "Questions?": "Call 800-824-1706 Monday - Friday 9am - 4 pm MST", "Package label": "WINCO FOODS Children's Pain Relief Dye Free Grape Flavor", "Other information": "each 5 mL contains: sodium 2 mg store between 20-25 o C(68-77 o F) do not refrigerate see bottom panel for lot number and expiration date", "Inactive ingredients": "butylparaben, microcrystalline cellulose, carboxymethylcellulose sodium, citric acid,flavors, glycerin, high fructose corn syrup, propylene glycol, purified water, sodium benzoate, sorbitol,sucralose, xanthan gum", "Principal Display Panel": "**Compare to the active ingredient in Children's TYLENOL® Oral Suspension ORAL SUSPENSION Pain Relief Children's ACETAMINOPHEN 160 mg per 5 mL / PAIN RELIEVER - FEVER REDUCER Alcohol Free Aspirin & Inuprofen Free For Ages 2-11 Years Dye Free Grape Flavor FL OZ (mL) **This product is not manufactured or distributed by McNEIL CONSUMER HEALTHCARE, distributor of Children's TYLENOL® Oral Suspension. KEEP OUTER CARTON FOR COMPLETE WARNINGS AMD PRODUCT INFORMATION. DISTRIBUTED BY: WINCO FOODS, LLC BOISE, ID 83704 Comments or Question? 800-824-1706 www.wincofoods.com", "When using this product": "do not exceed recommended dose (see overdose warning)", "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 redness or swelling is present new symptoms occur These could be signs of a serious condition.", "Keep out of reach of children.": "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 for adults as well as for children even if you do not notice any signs or symptoms.", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg", "Ask a doctor before use if your child has": "liver disease", "Ask a doctor or pharmacist before use if your child is": "taking the blood thinning drug warfarin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:57.036416 · Updated: 2026-03-14T23:02:46.668637