Dye Free Childrens Acetaminophen
a69fca9d-c0a0-4321-bf03-5c8e99cc07cc
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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.
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Raw Label Data
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Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:05:29.466368 · Updated: 2026-03-14T23:07:24.321893