Pediacare ®

Pediacare ®
SPL v2
SPL
SPL Set ID f9d531a2-234c-4feb-8f05-212dbee83dfe
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:
    • sore throat
    • the common cold
    • flu
    • headache
    • 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.
  • repeat dose every 4 hours while symptoms last
  • measure only with dosage cup provided
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
Weight (lb.) Age (yrs.) Dose (ml)
always check with your doctor before administering medicine to your infant/child
Under 24 Under 2 Ask a doctor
24 – 35 2 - 3 5mL
36 – 47 4 - 5 7.5 mL
48 – 59 6 - 8 10mL
60 – 71 9 - 10 12.5mL
72- 95 11 15mL
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. 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
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.

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 118 Ml Bottle Carton

Fast Acting

Pedia

Care ®

100% dedicated

to kids™

2-11 Years

ACETAMINOPHEN

Pain Reliever/

Fever Reducer

Acetaminophen (160 mg per 5mL)

Oral Suspension

Alcohol Free

Asprin Free

Ibuprofen Free

No Parabens

Grape Flavor

4 FL OZ (118 mL)

160 mg per 5 mL

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • sore throat
    • the common cold
    • flu
    • headache
    • 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.
  • repeat dose every 4 hours while symptoms last
  • measure only with dosage cup provided
  • do not give more than 5 times in 24 hours
  • do not give more than 5 days unless directed by a doctor.
Weight (lb.) Age (yrs.) Dose (ml)
always check with your doctor before administering medicine to your infant/child
Under 24 Under 2 Ask a doctor
24 – 35 2 - 3 5mL
36 – 47 4 - 5 7.5 mL
48 – 59 6 - 8 10mL
60 – 71 9 - 10 12.5mL
72- 95 11 15mL
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)

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • Store between 15° - 30° C (59° - 86° F)
  • Protect from Freezing
  • Protect from Light
Sore Throat Warning (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.

Inactive Ingredients (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 (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 118 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton)

Fast Acting

Pedia

Care ®

100% dedicated

to kids™

2-11 Years

ACETAMINOPHEN

Pain Reliever/

Fever Reducer

Acetaminophen (160 mg per 5mL)

Oral Suspension

Alcohol Free

Asprin Free

Ibuprofen Free

No Parabens

Grape Flavor

4 FL OZ (118 mL)

160 mg per 5 mL

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:11.082431 · Updated: 2026-03-14T23:06:36.654428