Children's Pain & Fever Grape Flavor

SPL v3

SPL

SPL Set ID 9064943f-836f-4853-b6f2-2c4879941eeb

Route

ORAL

Published

Effective Date 2024-02-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Anhydrous Citric Acid Butylparaben D&c Red No. 33 Fd&c Blue No. 1 Glycerin High Fructose Corn Syrup Cellulose, Microcrystalline Carboxymethylcellulose Sodium Propylene Glycol Water Sodium Benzoate Sorbitol Solution Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2013-08-21

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

Liver warning

This product contains acetaminophen. Severe liver

damage may occur nyour 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.

Indications and Usage

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration

Directions (Children's Pain & Fever)

■ 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 or tsp)*
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 tsp0
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.

Directions (Infants' Pain Relief)

■ 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

*or as directed by a doctor

Attention: use only enclosed dosing syringe specifially

designed for use with this product. Do not use any

other dosing device.

Description

Drug Facts

Section 34088-5

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. (1-800-222-1222) Quick medical attention is critical

for adults as well as for children even if you

do not notice any signs or symptoms.

Section 42229-5

Drug Facts

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 ■ 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 other of

the inactive ingredients in this product.

Section 51727-6

Inactive ingredients anhydrous citric acid,

butylparaben. D&C Red #33. FD&C Blue #1. flavor,

glycerin, high fructose corn syrup, microcrystalline

cellulose and carboxymethylcellulose sodium.

propylene glycol, purified water, sodium benzoate,

sorbitol solution, sucralose, xanthan gum.

Section 53413-1

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Section 55105-1

Purpose

Pain reliever/fever reducer

Section 55106-9

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8

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.

Product Label

AP SAFE ^® NDC 76821-526-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S TYLENOL^®

ORAL SUSPENSION*

Children's

Pain

& Fever

Acetaminophen

Oral Suspension

Pain reliever/Fever Reducer

• Alcohol-Free

• Ibuprofen Free

• Aspirin Free

• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Grape Flavor

DO NOT USE IF PRINTED NECK BAND IS

BROKEN OR MISSING

**This product is not manufactured or distributed

by McNeil Consumer Healthcare, distributor of

Children's Tylenol^®Oral Suspension.

Manufactured by:

AptaPharma Inc.

1533 Union Ave.

Pennsauken. NJ 08110

AP-BX-06

Carton

Bottle

Carton

Bottle

res

Structured Label Content

Indications and Usage (34067-9)

Uses temporarily ■ reduces fever

■ relieves minor aches and pains due to:

■ the common cold ■ flu ■ headache ■ sore throat

■ toothache

Dosage and Administration (34068-7)

Weight (lb)	Age (yr)	Dose (mL or tsp)*
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 tsp0
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.

Weight (lb)	Age (Yr)	Dose (mL)*
Under 24	Under 2 years	Ask a doctor
24-35	2-3 years	5 mL

*or as directed by a doctor

Attention: use only enclosed dosing syringe specifially

designed for use with this product. Do not use any

other dosing device.

Warnings and Precautions (34071-1)

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.

Section 34088-5 (34088-5)

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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)

Section 51727-6 (51727-6)

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30 AM to 4:30

PM EST at 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Section 55106-9 (55106-9)

Active ingredient

(in each 5 mL = 1 teaspoonful)

Acetaminophen 160 mg

Section 60561-8 (60561-8)

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.

Product Label

AP SAFE ^® NDC 76821-526-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S TYLENOL^®

ORAL SUSPENSION*

Children's

Pain

& Fever

Acetaminophen

Oral Suspension

Pain reliever/Fever Reducer

• Alcohol-Free

• Ibuprofen Free

• Aspirin Free

• For Ages 2 to 11

4 FL OZ (118 mL)

160 mg per 5 mL

Grape Flavor

DO NOT USE IF PRINTED NECK BAND IS

BROKEN OR MISSING

**This product is not manufactured or distributed

by McNeil Consumer Healthcare, distributor of

Children's Tylenol^®Oral Suspension.

Manufactured by:

AptaPharma Inc.

1533 Union Ave.

Pennsauken. NJ 08110

AP-BX-06

Carton

Bottle

Carton

Bottle

res

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Uses temporarily ■ reduces fever ■ relieves minor aches and pains due to: ■ the common cold ■ flu ■ headache ■ sore throat ■ toothache", "34068-7": "Directions (Children's Pain & Fever) ■ 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 or tsp)* 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 tsp0 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. Directions (Infants' Pain Relief) ■ 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 *or as directed by a doctor Attention: use only enclosed dosing syringe specifially designed for use with this product. Do not use any other dosing device.", "34071-1": "Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur nyour 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.", "34088-5": "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. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "42229-5": "Drug Facts", "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 ■ 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 other of the inactive ingredients in this product.", "51727-6": "Inactive ingredients anhydrous citric acid, butylparaben. D&C Red #33. FD&C Blue #1. flavor, glycerin, high fructose corn syrup, microcrystalline cellulose and carboxymethylcellulose sodium. propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, xanthan gum.", "53413-1": "Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944", "55105-1": "Purpose Pain reliever/fever reducer", "55106-9": "Active ingredient (in each 5 mL = 1 teaspoonful) Acetaminophen 160 mg", "60561-8": "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.", "Product Label": "AP SAFE ® NDC 76821-526-24 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S TYLENOL ® ORAL SUSPENSION* Children's Pain & Fever Acetaminophen Oral Suspension Pain reliever/Fever Reducer • Alcohol-Free • Ibuprofen Free • Aspirin Free • For Ages 2 to 11 4 FL OZ (118 mL) 160 mg per 5 mL Grape Flavor DO NOT USE IF PRINTED NECK BAND IS BROKEN OR MISSING **This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Children's Tylenol ® Oral Suspension. Manufactured by: AptaPharma Inc. 1533 Union Ave. Pennsauken. NJ 08110 AP-BX-06 Carton Bottle Carton Bottle res"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:45.962813 · Updated: 2026-03-14T23:02:29.359860