Acetaminophen Oral Suspension
caf5daea-409e-5dd2-e053-2995a90acb12
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Drug Facts
Purpose
Pain reliever/fever reducer
How Supplied
grape flavored suspension supplied in the following oral dosage forms: NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups. NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
Medication Information
Purpose
Pain reliever/fever reducer
How Supplied
- grape flavored suspension supplied in the following oral dosage forms:
NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups.
NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
Description
Drug Facts
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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 the user is taking the blood thinning drug warfarin
Section 50569-3
Ask a doctor before use if the user has liver disease
Section 53413-1
Call 1-800-845-8210.
Section 53414-9
If pregnant or breast-feeding, ask a health professional before use.
Directions
- Use as directed per healthcare professional.
- do not take more than directed (see overdose warning)
- shake well before using
- 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 take 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 |
| Over 96 | adults and children 12 years and over | 20 mL |
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 you have ever had an allergic reaction to this product or any of its ingredients
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.
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Manufactured By
Pharmaceutical Associates, Inc.
Greenville, SC 29860
www.paipharma.com
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 for children even if you do not notice any signs or symptoms.
Other Information
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
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.
Inactive Ingredients
acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.
Stop Use and Ask A Doctor If
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
- do not give this product to children for the pain of arthritis unless directed by a doctor
Active Ingredient (in Each 5 Ml)
Acetaminophen 160 mg
Principal Display Panel 5 Ml Cup Label
NDC 0121-0941-05
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.
Greenville, SC 29605
Principal Display Panel 20.3 Ml Cup Label
NDC 0121-2823-21
ACETAMINOPHEN ORAL SUSPENSION
650 mg per 20.3 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.
Greenville, SC 29605
Principal Display Panel 10.15 Ml Cup Label
NDC 0121-1882-11
ACETAMINOPHEN ORAL SUSPENSION
325 mg per 10.15 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.
Greenville, SC 29605
Structured Label Content
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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 the user is taking the blood thinning drug warfarin
Section 50569-3 (50569-3)
Ask a doctor before use if the user has liver disease
Section 53413-1 (53413-1)
Call 1-800-845-8210.
Section 53414-9 (53414-9)
If pregnant or breast-feeding, ask a health professional before use.
Purpose
Pain reliever/fever reducer
Directions
- Use as directed per healthcare professional.
- do not take more than directed (see overdose warning)
- shake well before using
- 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 take 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 |
| Over 96 | adults and children 12 years and over | 20 mL |
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 you have ever had an allergic reaction to this product or any of its ingredients
How Supplied
- grape flavored suspension supplied in the following oral dosage forms:
NDC 0121-0941-05: 5 mL unit dose cup, in a tray of ten cups.
NDC 0121-1882-11: 10.15 mL unit dose cup, in a tray of ten cups.
NDC 0121-2823-21: 20.3 mL unit dose cup, in a tray of ten cups.
Allergy Alert (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.
Liver Warning (Liver warning)
This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg of acetaminophen in 24 hours
- child takes more than 5 doses in 24 hours
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
Manufactured By (MANUFACTURED BY)
Pharmaceutical Associates, Inc.
Greenville, SC 29860
www.paipharma.com
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 for adults as well as for children even if you do not notice any signs or symptoms.
Other Information (Other information)
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
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.
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, butylparaben, citric acid anhydrous, flavoring, glycerin, high fructose corn syrup, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, and xanthan gum.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- pain gets worse or lasts more than 10 days (for adults) or 5 days (for children)
- 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.
- do not give this product to children for the pain of arthritis unless directed by a doctor
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 0121-0941-05
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.
Greenville, SC 29605
Principal Display Panel 20.3 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 20.3 mL Cup Label)
NDC 0121-2823-21
ACETAMINOPHEN ORAL SUSPENSION
650 mg per 20.3 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.
Greenville, SC 29605
Principal Display Panel 10.15 Ml Cup Label (PRINCIPAL DISPLAY PANEL - 10.15 mL Cup Label)
NDC 0121-1882-11
ACETAMINOPHEN ORAL SUSPENSION
325 mg per 10.15 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.
Greenville, SC 29605
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Source: dailymed · Ingested: 2026-02-15T12:06:48.758479 · Updated: 2026-03-14T23:09:46.965889