Children's Acetaminophen Oral Suspension

Children's Acetaminophen Oral Suspension
SPL v13
SPL
SPL Set ID 46d9d8cd-e3db-492c-9386-7e8255beff64
Route
ORAL
Published
Effective Date 2021-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (160 mg)
Inactive Ingredients
Magnesium Aluminum Silicate Acesulfame Potassium Butylparaben Anhydrous Citric Acid Fd&c Red No. 40 Glycerin High Fructose Corn Syrup Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: red
Marketing Status
OTC MONOGRAPH DRUG Active Since 2007-09-17

Description

Acetaminophen 160 mg

Purpose

Pain reliever/fever reducer


Medication Information

Purpose

Pain reliever/fever reducer

Description

Acetaminophen 160 mg

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pain due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R09/20

Section 50565-1

Keep out of the reach of children.

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 children even if you do not notice any sign or symptoms

Warnings

Liver warning: This product contains 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

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening

• blisters

• rash

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

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

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.

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product, do not exceed the recommended dose (see overdose warning)

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.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find the 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 (lbs) Age (yr) Dose (mL)
or as directed by a doctor
Under 24 Under 2 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 2 mg
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • protect from freezing
  • a red, berry flavored suspension supplied in the following oral dosage form:

NDC 0121-1781-05:  5 mL unit dose cup, in a tray of ten cups

Inactive Ingredients

Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments?

Call 1-800-845-8210.

Principal Display Panel 5 Ml Cup

Delivers 5 mL

NDC 0121-1781-05

CHILDREN'S ACETAMINOPHEN  ORAL SUSPENSION

160 mg per 5 mL

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL BEFORE USING

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Active Ingredient                                                                                 

Acetaminophen 160 mg


Structured Label Content

Uses

temporarily:

  • reduces fever
  • relieves minor aches and pain due to:

    • the common cold
    • flu
    • headache
    • sore throat
    • toothache
Section 42229-5 (42229-5)

MANUFACTURED BY

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R09/20

Section 50565-1 (50565-1)

Keep out of the reach of children.

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 children even if you do not notice any sign or symptoms

Purpose

Pain reliever/fever reducer

Warnings

Liver warning: This product contains 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

Allergy alert: acetaminophen may cause severe skin reactions.

Symptoms may include:

• skin reddening

• blisters

• rash

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

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

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.

Ask a doctor before use if your child has liver disease.

Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product, do not exceed the recommended dose (see overdose warning)

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.

Directions
  • this product does not contain directions or complete warnings for adult use
  • do not take more than directed (see overdose warning)
  • shake well before using
  • mL = milliliter
  • find the 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 (lbs) Age (yr) Dose (mL)
or as directed by a doctor
Under 24 Under 2 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 2 mg
  • Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]
  • protect from freezing
  • a red, berry flavored suspension supplied in the following oral dosage form:

NDC 0121-1781-05:  5 mL unit dose cup, in a tray of ten cups

Inactive Ingredients (Inactive ingredients)

Acesulfame K, butylparaben, citric acid, FD&C Red No. 40, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Questions Or Comments? (Questions or comments?)

Call 1-800-845-8210.

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

Delivers 5 mL

NDC 0121-1781-05

CHILDREN'S ACETAMINOPHEN  ORAL SUSPENSION

160 mg per 5 mL

Ibuprofen Free/ Alcohol Free / Aspirin Free

SHAKE WELL BEFORE USING

Package Not Child-Resistant

PHARMACEUTICAL ASSOCIATES, INC.

GREENVILLE, SC 29605

SEE INSERT

Active Ingredient                                                                                  (Active ingredient                                                                                 )

Acetaminophen 160 mg


Advanced Ingredient Data


Raw Label Data

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