Children's Acetaminophen Oral Suspension
46d9d8cd-e3db-492c-9386-7e8255beff64
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:43.616021 · Updated: 2026-03-14T23:03:56.622228