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
Purpose

Pain reliever/fever reducer

Description

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

Medication Information

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. 

Purpose

Pain reliever/fever reducer

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.

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.

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

Description

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

Principal Display Panel
Children's Pain Relief
Use(s)

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

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. 

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)

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

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. 

Purpose

Pain reliever/fever reducer

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.

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.

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
Use(s)

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

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. 

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)

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