Pediacare ® - DailyMed Details

Pediacare ®

SPL v3

SPL

SPL Set ID 596372c7-eca3-4527-8e22-ab0751e2526b

Route

ORAL

Published

Effective Date 2022-12-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (160 mg)

Inactive Ingredients

Acesulfame Potassium Citric Acid Monohydrate Corn Syrup Fd&c Blue No. 1 D&c Red No. 33 Glycerin Microcrystalline Cellulose Polysorbate 60 Propylene Glycol Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Pill Appearance

Color: purple

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-01-03

Description

Drug Facts

Purpose

Pain reliever/fever reducer

Medication Information

Purpose

Pain reliever/fever reducer

Description

Drug Facts

Uses

temporarily:

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

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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 istaking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child hasliver disease

Directions

this product does not contain directions or complete warnings for adult use.
Shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
only use enclosed measuring syringe
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) or as directed by doctor
under 24	under 2 yr	ask a doctor
24-35	2-3 yr	5 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

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

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.

Other Information

Store between 15° - 30° C (59° - 86° F)
Protect from Freezing
Protect from Light

Inactive Ingredients

acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum

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.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg

Principal Display Panel 30 Ml Bottle Carton

Fast Acting

Pedia

Care ^®

100% dedicated

to kids™

Infants

ACETAMINOPHEN

Pain Reliever/

Fever Reducer

Acetaminophen (160 mg per 5mL)

Oral Suspension

Alcohol Free, Asprin Free

Ibuprofen Free, No Parabens

Grape Flavor

(Use Only Enclosed Syringe)

1 FL OZ (30mL)

160 mg per 5 mL

Structured Label Content

Uses

temporarily:

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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 istaking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child hasliver disease

Purpose

Pain reliever/fever reducer

Directions

this product does not contain directions or complete warnings for adult use.
Shake well before using
mL = milliliter
find right dose on chart below. If possible, use weight to dose; otherwise, use age.
only use enclosed measuring syringe
repeat dose every 4 hours while symptoms last
do not give more than 5 times in 24 hours

Weight (lb)	Age (yr)	Dose (mL) or as directed by doctor
under 24	under 2 yr	ask a doctor
24-35	2-3 yr	5 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

Liver Warning (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

Overdose Warning (Overdose warning)

Other Information (Other information)

Store between 15° - 30° C (59° - 86° F)
Protect from Freezing
Protect from Light

Inactive Ingredients (Inactive ingredients)

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.

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

Acetaminophen 160 mg

Principal Display Panel 30 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton)

Fast Acting

Pedia

Care ^®

100% dedicated

to kids™

Infants

ACETAMINOPHEN

Pain Reliever/

Fever Reducer

Acetaminophen (160 mg per 5mL)

Oral Suspension

Alcohol Free, Asprin Free

Ibuprofen Free, No Parabens

Grape Flavor

(Use Only Enclosed Syringe)

1 FL OZ (30mL)

160 mg per 5 mL

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 headache flu sore throat toothache", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children.", "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", "Purpose": "Pain reliever/fever reducer", "Directions": "this product does not contain directions or complete warnings for adult use. Shake well before using mL = milliliter find right dose on chart below. If possible, use weight to dose; otherwise, use age. only use enclosed measuring syringe repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours Weight (lb) Age (yr) Dose (mL) or as directed by doctor under 24 under 2 yr ask a doctor 24-35 2-3 yr 5 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", "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", "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.", "Other information": "Store between 15° - 30° C (59° - 86° F) Protect from Freezing Protect from Light", "Inactive ingredients": "acesulfame potassium, citric acid, corn syrup, FD&C blue #1, FD&C red #33 flavor, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate, propylene glycol, prosweet N & AK, purified water, sodium benzoate, sorbitol, sucralose, xanthan gum", "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.", "Active ingredient (in each 5 mL)": "Acetaminophen 160 mg", "PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton": "Fast Acting Pedia Care ® 100% dedicated to kids™ Infants ACETAMINOPHEN Pain Reliever/ Fever Reducer Acetaminophen (160 mg per 5mL) Oral Suspension Alcohol Free, Asprin Free Ibuprofen Free, No Parabens Grape Flavor (Use Only Enclosed Syringe) 1 FL OZ (30mL) 160 mg per 5 mL"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:09.273236 · Updated: 2026-03-14T23:06:32.989437