Childen's Acetaminophen Oral Suspension
Childrens Acetaminophen by
Drug Labeling and Warnings
Childrens Acetaminophen by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Associates, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
CHILDRENS ACETAMINOPHEN- acetaminophen suspension
PAI Holdings, LLC dba PAI Pharma
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Childen's Acetaminophen Oral Suspension
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
Warnings
Liver warning
This product contains acetaminophen. Severe liver damage may occur if
- 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 you have ever had an allergic reaction to this product or any of its ingredients
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
| 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 |
| Over 96 | adults and children 12 years and over | 20 mL |
Other information
- each 5 mL contains: sodium: 2 mg
- Store at 20° to 25°C (68° to 77°F)
- berry flavored suspension supplied in the following oral dosage forms:
NDC: 0121-0939-05: 5 mL unit dose cup, in a tray of ten cups.
NDC: 0121-1878-10: 10 mL unit dose cup, in a tray of ten cups.
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.
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Delivers 5 mL
NDC: 0121-0939-05
CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION
160 mg per 5 mL
DYE FREE
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
SEE INSERT
PRINCIPAL DISPLAY PANEL - 10 mL Cup Label
Delivers 10 mL
NDC: 0121-1878-10
CHILDREN'S ACTAMINOPHEN ORAL SUSPENSION
320 mg per 10 mL
DYE FREE
Ibuprofen Free/Alcohol Free/Aspirin Free
Pain Reliever-Fever Reducer
SHAKE WELL BEFORE USING
Package Not Child-Resistant
Pharmaceutical Associates, Inc.
Greenville, SC 29605
SEE INSERT
| CHILDRENS ACETAMINOPHEN
acetaminophen suspension |
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| CHILDRENS ACETAMINOPHEN
acetaminophen suspension |
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| Labeler - PAI Holdings, LLC dba PAI Pharma (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| PAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma | 097630693 | label(0121-0939, 0121-1878) , manufacture(0121-0939, 0121-1878) | |