Dye Free Childrens Acetaminophen  

Dye Free Childrens Acetaminophen  
SPL v8
SPL
SPL Set ID a69fca9d-c0a0-4321-bf03-5c8e99cc07cc
Route
ORAL
Published
Effective Date 2025-02-03
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 High Fructose Corn Syrup Polysorbate 80 Propylene Glycol Water Sodium Benzoate Sorbitol Solution Xanthan Gum

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-09

Description

(in each 5 mL) Acetaminophen 160 mg

Purpose

Acetaminophen 160 mg.............................Pain reliever/fever reducer


Medication Information

Purpose

Acetaminophen

160 mg.............................Pain reliever/fever reducer

Description

(in each 5 mL) Acetaminophen 160 mg

Uses
  • reduces fever
  • minor aches and pains due to:

• the common cold • flu • headache • sore throat • toothache

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 51727-6

Inactive ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Warnings

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

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.

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 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

Attention: For Single-Dose Cups, the entire dose should be taken.

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

*or as directed by a doctor

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
Manufactured By:

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R01/22

Active Ingredient

(in each 5 mL)

Acetaminophen 160 mg

Other Information
  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)
  • grape flavored suspension supplied in the following oral dosage form:

   NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.

   NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

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.

Questions Or Comments?

Call 1-800-845-8210.

Principal Display Panel

Delivers 5 mL

NDC 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT

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.


Structured Label Content

Uses
  • reduces fever
  • minor aches and pains due to:

• the common cold • flu • headache • sore throat • toothache

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 51727-6 (51727-6)

Inactive ingredients: acesulfame K, butylparaben, citric acid, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.

Purpose

Acetaminophen

160 mg.............................Pain reliever/fever reducer

Warnings

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

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.

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 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

Attention: For Single-Dose Cups, the entire dose should be taken.

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

*or as directed by a doctor

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
Manufactured By: (MANUFACTURED BY:)

Pharmaceutical Associates, Inc.

Greenville, SC 29605

www.paipharma.com

R01/22

Active Ingredient (Active ingredient)

(in each 5 mL)

Acetaminophen 160 mg

Other Information (Other information)
  • each 5 mL contains: sodium: 2 mg
  • Store at 20° to 25°C (68° to 77°F)
  • grape flavored suspension supplied in the following oral dosage form:

   NDC 0121-0966-05: 5 mL unit dose cup, in a tray of ten cups.

   NDC 0121-0966-94: Case contains 30 unit dose cups of 5 mL (0121-0966-05) packaged in 3 trays of 10 unit dose cups each.

   NDC 0121-0966-00: Case contains 100 unit dose cups of 5 mL (0121-0966-05) packaged in 10 trays of 10 unit dose cups each.

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.

Questions Or Comments? (Questions or Comments?)

Call 1-800-845-8210.

Principal Display Panel

Delivers 5 mL

NDC 0121-0966-05

DYE FREE/GRAPE FLAVOR

Children's Acetaminophen Oral Suspension

160 mg per 5 mL

DYE FREE/GRAPE FLAVOR

Ibuprofen Free/Alcohol Free/Aspirin Free

Pain Reliever-Fever Reducer

SHAKE WELL BEFORE USING

Package Not Child-Resistant

Pharmaceutical Associates, Inc.

SEE INSERT

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.


Advanced Ingredient Data


Raw Label Data

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