Children's Pain Relief

Children's Pain Relief
SPL v1
SPL
SPL Set ID e697cdaf-b842-41ed-bb05-a324de0533d8
Route
ORAL
Published
Effective Date 2014-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Xanthan Gum Carboxymethylcellulose Powdered Cellulose Methylparaben Propylparaben Sucralose Saccharin Sodium Propylene Glycol Polyethylene Glycol 1450 High Fructose Corn Syrup Glycerin Sorbitol D&c Red No. 33 Fd&c Blue No. 2 Water

Identifiers & Packaging

Pill Appearance
Color: purple
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-10-03
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
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5

Drug Facts

Section 50565-1

Keep this and all drugs out of the reach of children.

Section 50568-5

Ask a doctor or pharmacist before use if the 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 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
Directions
  • this product does not contain directions or complete warnings for adult use
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • tsp = teaspoon, mL = milliliter
  • if needed, repeat dose every 4 hours while symptoms last
  • 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 (yr) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 1 tsp or 5 mL
36-47 4-5 1½ tsps or 7.5 mL
48-59 6-8 2 tsps or 10 mL
60-71 9-10 2½ tsps or 12.5 mL
72-95 11 3 tsps or 15 mL
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) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information
  • store at controlled room temperature
  • dosage cup provided
  • each teaspoon contains: sodium 2 mg
Inactive Ingredients

Carboxymethylcellulose, FD&C Blue #1, D&C Red #33, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions Or Comments?

1-732-249-6363

When Using This Product
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 for more than 3 days. These could be signs of a serious condition.
Active Ingredient (in Each 5 Ml, 1 Teaspoon)

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Label

NDC 68016-141-04

Premier

Value ®

Children's

Pain Relief

PAIN RELIEVER - FEVER REDUCER

ACETAMINOPHEN

SUSPENSION LIQUID

• Alcohol Free

• Aspirin Free

• Ibuprofen Free

Grape

Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pains due to:
    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep this and all drugs out of the reach of children.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the 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)

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
Purpose

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use
  • shake well before using
  • find right dose on chart below. If possible, use weight to dose: otherwise, use age.
  • use only enclosed dosing cup designed for use with this product. Do not use any other dosing device
  • tsp = teaspoon, mL = milliliter
  • if needed, repeat dose every 4 hours while symptoms last
  • 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 (yr) Dose (tsp or mL)
under 24 under 2 ask a doctor
24-35 2-3 1 tsp or 5 mL
36-47 4-5 1½ tsps or 7.5 mL
48-59 6-8 2 tsps or 10 mL
60-71 9-10 2½ tsps or 12.5 mL
72-95 11 3 tsps or 15 mL
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

Taking more than the recommended dose (overdose) could cause serious health problems including liver damage. In case of accidental overdose, seek professional assistance or contact a Poison Control Center (1-800-222-1222) immediately. Quick medical attention is critical even if you do not notice any signs or symptoms.

Other Information (Other information)
  • store at controlled room temperature
  • dosage cup provided
  • each teaspoon contains: sodium 2 mg
Inactive Ingredients (Inactive ingredients)

Carboxymethylcellulose, FD&C Blue #1, D&C Red #33, Flavors, Glycerin, High Fructose Corn Syrup, Methylparaben, Microcrystalline Cellulose, Polyethylene Glycol 1450, Propylene Glycol, Propylparaben, Purified Water, Saccharin Sodium, Sorbitol Solution, Sucralose Powder, Xanthan Gum

Questions Or Comments? (Questions or comments?)

1-732-249-6363

When Using This Product (When using this product)
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 for more than 3 days. These could be signs of a serious condition.
Active Ingredient (in Each 5 Ml, 1 Teaspoon) (Active ingredient (in each 5 mL, 1 teaspoon))

Acetaminophen 160 mg

Principal Display Panel 118 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label)

NDC 68016-141-04

Premier

Value ®

Children's

Pain Relief

PAIN RELIEVER - FEVER REDUCER

ACETAMINOPHEN

SUSPENSION LIQUID

• Alcohol Free

• Aspirin Free

• Ibuprofen Free

Grape

Flavor

4 FL OZ (118 mL)

INDEPENDENTLY TESTED

PV

SATISFACTION GUARANTEED

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:51.542409 · Updated: 2026-03-14T22:53:52.491278