455 - Children Pain Relief Oral Suspension

455 - Children Pain Relief Oral Suspension
SPL v3
SPL
SPL Set ID 7381dd26-c507-4d02-b989-cfd96e02f495
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 Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Microcrystalline Cellulose Carboxymethylcellulose Sodium, Unspecified Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-11
Description

Acetaminophen 160 mg  (in each 5 mL = 1 teaspoonful)

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg  (in each 5 mL = 1 teaspoonful)

Use(s)

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 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 ever, headache, rash. nausea or vomiting, consult a doctor promptly. 

Directions

■ this product does not contain directions or complete warnings for adult use.■ shake well before using

■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.

■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours

■ do not give for more than 5 days unless directed by a doctor

Weight (lb) Age (yr) Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL(1 tsp)

36-47

4-5 years

7.5 mL(1 1/2 tsp)

48-59

6-8 years

10 mL(2 tsp)

60-71

9-10 years

12.5 mL(2 1/2 tsp)

72-95

11 years

15 mL(3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this

product. Do not use any other dosing device.

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 other of the inactive ingredients in this product. 

Other Information

■ each 5 mL (1 tsp) contains; sodium 3 mg ■ store between 20-25ºC (68-77ºF) ■ do not refrigerate ■ Keep carton for full directions for use.

Questions/comments

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Active Ingredient(s)

Acetaminophen 160 mg 

(in each 5 mL = 1 teaspoonful)

Inactive Ingredients

anhydrous citric acid, butylparaben, FD&C red

#40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium

benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel
Children's Pain Relief
When Using This Product

do not exceed recommended dose (see overdose warning)

Ask A Doctor Before Use If

your child has liver disease

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 ■ redness or swelling is present. 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

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

symptoms.

Ask A Doctor Or Pharmacist Before Use If

your child is taking the blood thinning drug warfarin.

Structured Label Content

Use(s)

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 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 ever, headache, rash. nausea or vomiting, consult a doctor promptly. 

Directions

■ this product does not contain directions or complete warnings for adult use.■ shake well before using

■ mL = milliliter; tsp = teaspoonful ■ find the right dose on the chart below. If possible, use weight to dose, otherwise, use age.

■ if needed, repeat dose every 4 hours while symptoms last ■ do not give more than 5 times in 24 hours

■ do not give for more than 5 days unless directed by a doctor

Weight (lb) Age (yr) Dose (mL)*

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL(1 tsp)

36-47

4-5 years

7.5 mL(1 1/2 tsp)

48-59

6-8 years

10 mL(2 tsp)

60-71

9-10 years

12.5 mL(2 1/2 tsp)

72-95

11 years

15 mL(3 tsp)

*or as directed by a doctor

Attention: use only enclosed dosing cup specifically designed for use with this

product. Do not use any other dosing device.

Do Not Use (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 other of the inactive ingredients in this product. 

Other Information (Other information)

■ each 5 mL (1 tsp) contains; sodium 3 mg ■ store between 20-25ºC (68-77ºF) ■ do not refrigerate ■ Keep carton for full directions for use.

Questions/comments (Questions/Comments)

Call 1-888-952-0050 Monday through Friday 9AM - 5PM EST

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 160 mg 

(in each 5 mL = 1 teaspoonful)

Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, butylparaben, FD&C red

#40, flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and

carboxymethylcellulose sodium, propylene glycol, purified water, sodium

benzoate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel
Children's Pain Relief
When Using This Product (When using this product)

do not exceed recommended dose (see overdose warning)

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

your child has liver disease

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

Keep Out of Reach of Children (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

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

symptoms.

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

your child is taking the blood thinning drug warfarin.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:13.950582 · Updated: 2026-03-14T23:03:10.704753