Drug Facts

Drug Facts

SPL v8

SPL

SPL Set ID 41633554-474e-4d3c-9187-d90487d2ae8c

Route

ORAL

Published

Effective Date 2023-12-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Carboxymethylcellulose Sodium Acesulfame Potassium Butylparaben Cellulose, Microcrystalline Anhydrous Citric Acid Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Propylene Glycol Water Sodium Benzoate Sorbitol Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2015-04-30

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

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 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, use age.

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

Product Label

DOLLAR GENERAL Children's Pain Relief Cherry Flavor

Other Information

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

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum

Questions Or Comments?

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredients of Children's Tylenol® Oral Suspension**

For Ages 2 to 11 Years

Children's Pain Relief

Acetaminophen 160 mg per 5 mL

Oral Suspension

Pain Reliever/Fever Reducer

alcohol free
aspirin free
ibuprofen free

Fast, effective relief of children's fever and pain

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETSVILLE, TN 37072

When Using This Product

do not exceed recommended dosage (see overdose warning)

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.

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 (1-800-222-1222) right away. Quick medical attention is critical 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
temporarily 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 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 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, use age.

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

Product Label

DOLLAR GENERAL Children's Pain Relief Cherry Flavor

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Questions Or Comments? (Questions or comments?)

Call 1-888-309-9030

Principal Display Panel

Compare to active ingredients of Children's Tylenol® Oral Suspension**

For Ages 2 to 11 Years

Children's Pain Relief

Acetaminophen 160 mg per 5 mL

Oral Suspension

Pain Reliever/Fever Reducer

alcohol free
aspirin free
ibuprofen free

Fast, effective relief of children's fever and pain

Cherry Flavor

FL OZ (mL)

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE

GOODLETSVILLE, TN 37072

When Using This Product (When using this product)

do not exceed recommended dosage (see overdose warning)

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.

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 temporarily 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 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 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, use age. Weight (lb) Age (year) Dose (mL) under 24 under 2 ask a doctor 24-35 2-3 5 mL 36-47 4-5 7.5 ml 48-59 6-8 10 mL 60-71 9-10 12.5 mL 72-95 11 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", "Product Label": "DOLLAR GENERAL Children's Pain Relief Cherry Flavor", "Other information": "each 5 mL contains: sodium 2 mg store between 20-25ºC (68-77ºF) do not refrigerate see bottom panel for lot number and expiration date", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, butylparaben, carboxymethylcellulose sodium, FD&C red #40, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purified water, sodium benzoate, sorbitol, xanthan gum", "Questions or comments?": "Call 1-888-309-9030 ", "Principal Display Panel": "Compare to active ingredients of Children's Tylenol® Oral Suspension** For Ages 2 to 11 Years Children's Pain Relief Acetaminophen 160 mg per 5 mL Oral Suspension Pain Reliever/Fever Reducer alcohol free aspirin free ibuprofen free Fast, effective relief of children's fever and pain Cherry Flavor FL OZ (mL) *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol® Oral Suspension TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE OR UNDER CAP IS BROKEN OR MISSING DISTRIBUTED BY DOLGENCORP, LLC 100 MISSION RIDGE GOODLETSVILLE, TN 37072", "When using this product": "do not exceed recommended dosage (see overdose warning)", "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.", "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 (1-800-222-1222) right away. Quick medical attention is critical 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: 2026-02-15T12:02:26.916056 · Updated: 2026-03-14T23:02:00.533418