dye free children's acetaminophen

dye free children's acetaminophen
SPL v4
SPL
SPL Set ID 5cc698fa-0841-4851-ae21-0aac8b40eb0a
Route
oral
Published
Effective Date 2025-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (160 mg)
Inactive Ingredients
anhydrous citric acid calcium sulfate, unspecified form carrageenan glycerin microcrystalline cellulose carboxymethylcellulose sodium, unspecified propylene glycol propylparaben water sodium benzoate sorbitol sucralose sodium phosphate, tribasic

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2022-08-02

Purpose

Pain reliever/fever reducer

How Supplied

NDC 68094-061-61 5 mL per unit dose cup One hundred (100) cups per shipper NDC 68094-061-62 5 mL per unit dose cup Thirty (30) cups per shipper

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
  • Use as directed per healthcare professional.
  • 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.
  • 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 a doctor
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
Other Information
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

How Supplied

NDC 68094-061-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-061-62

5 mL per unit dose cup

Thirty (30) cups per shipper

Description

Drug Facts

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 is taking the blood thinning drug warfarin

Section 50569-3

Ask a doctor before use if your child has liver disease

Section 53413-1

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

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 has ever had an allergic reaction to this product or any of its ingredients
Allergy Alert

Acetaminophen may cause a severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 even if you do not notice any signs or symptoms.

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.

Questions Or Comments?

1-800-397-9228

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

Principal Display Panel 5 Ml Cup Label

NDC 68094-061-59

PrecisionDose™

Children's ACETAMINOPHEN

Oral Suspension, 160 mg/5 mL

Dye

Free

Pkg: Precision Dose, Inc., S. Beloit, IL 61080


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
  • Use as directed per healthcare professional.
  • 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.
  • 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 a doctor
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
Other Information (Other information)
  • each 5 mL contains: sodium 3 mg
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, calcium sulfate, carrageenan, flavor, glycerin, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose, tribasic sodium phosphate

How Supplied

NDC 68094-061-61

5 mL per unit dose cup

One hundred (100) cups per shipper

NDC 68094-061-62

5 mL per unit dose cup

Thirty (30) cups per shipper

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 is taking the blood thinning drug warfarin

Section 50569-3 (50569-3)

Ask a doctor before use if your child has liver disease

Section 53413-1 (53413-1)

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email [email protected]

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 has ever had an allergic reaction to this product or any of its ingredients
Allergy Alert (Allergy alert)

Acetaminophen may cause a severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

If a skin reaction occurs, stop use and seek medical help right away.

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 even if you do not notice any signs or symptoms.

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.

Questions Or Comments? (Questions or comments?)

1-800-397-9228

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

Principal Display Panel 5 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 5 mL Cup Label)

NDC 68094-061-59

PrecisionDose™

Children's ACETAMINOPHEN

Oral Suspension, 160 mg/5 mL

Dye

Free

Pkg: Precision Dose, Inc., S. Beloit, IL 61080


Advanced Ingredient Data


Raw Label Data

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