children’s pain + fever relief

children’s pain + fever relief
SPL v3
SPL
SPL Set ID e4cbfb06-d826-4d08-95d6-60305c417625
Route
oral
Published
Effective Date 2024-02-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
carboxymethylcellulose sodium, unspecified anhydrous citric acid glycerin microcrystalline cellulose water sodium benzoate trisodium citrate dihydrate sorbitol solution sucralose xanthan gum

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
otc monograph drug active Since 2024-02-01

Purpose

Pain reliever/fever reducer

Description

Drug Facts


Medication Information

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

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL) **

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

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 contains: sodium 2 mg
  • store at room temperature
Inactive Ingredients

carboxymethylcellulose sodium, anhydrous citric acid, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Description

Drug Facts

Principal Display Panel

Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

NDC 51316-569-04

Children’s

Pain+Fever Relief

Acetaminophen

Oral Suspension

Pain Reliever-Fever Reducer

  • No Added Alcohol
  • Sugar Free
  • Dye Free
  • Aspirin Free
  • Ibuprofen Free
  • No Parabens

Ages 2-11 Years

Natural Strawberry Flavor

4 FL. OZ. (120 mL)

160 mg per 5 mL

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., the distributor of Children’s Tylenol® Dye-Free Oral Suspension.

Distributed by:

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

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 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

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.

Questions Or Comments?

1-866-467-2748

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 occur
  • redness or swelling is present

These could be signs of a serious condition.

Active Ingredient (in Each 5 Ml)

Acetaminophen 160 mg


Structured Label Content

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

Pain reliever/fever reducer

Directions
  • this product does not contain directions or complete warnings for adult use.
  • do not give more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find right dose on chart below. If possible, use weight to dose; otherwise, use age.
  • remove the child protective cap and squeeze your child's dose into the dosing cup
  • repeat dose every 4 hours while symptoms last
  • do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL) **

under 24

under 2 years

ask a doctor

24-35

2-3 years

5 mL

36-47

4-5 years

7.5 mL

48-59

6-8 years

10 mL

60-71

9-10 years

12.5 mL

72-95

11 years

15 mL

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 contains: sodium 2 mg
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

carboxymethylcellulose sodium, anhydrous citric acid, flavors, glycerin, microcrystalline cellulose, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, sucralose, xanthan gum

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Compare to the active ingredient in Children’s Tylenol® Dye-Free Oral Suspension*

NDC 51316-569-04

Children’s

Pain+Fever Relief

Acetaminophen

Oral Suspension

Pain Reliever-Fever Reducer

  • No Added Alcohol
  • Sugar Free
  • Dye Free
  • Aspirin Free
  • Ibuprofen Free
  • No Parabens

Ages 2-11 Years

Natural Strawberry Flavor

4 FL. OZ. (120 mL)

160 mg per 5 mL

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., the distributor of Children’s Tylenol® Dye-Free Oral Suspension.

Distributed by:

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

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 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)

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.

Questions Or Comments? (Questions or comments?)

1-866-467-2748

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 occur
  • redness or swelling is present

These could be signs of a serious condition.

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

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

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