CHILDRENS ACETAMINOPHEN- acetaminophen suspension
Pharmaceutical Associates, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Children's Acetaminophen
Uses
temporarily:
- reduces fever
- relieves minor aches and pain due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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; tsp = teaspoonful
- 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 (lb) | Age (yr) | Dose (mL or tsp)* |
|---|---|---|
|
||
| Under 24 | Under 2 | Ask a doctor |
| 24-35 | 2-3 years | 5 mL (1 tsp) |
| 36-47 | 4-5 years | 7.5 mL (1 ½ tsp) |
| 48-59 | 6-8 years | 10 mL (2 tsp) |
| 60-71 | 9-10 years | 12.5 mL (2 ½ tsp) |
| 72-95 | 11 years | 15 mL (3 tsp) |
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
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
When using this product, do not exceed the recommended dose (see overdose warning)
Other information
- sodium content: 2 mg/5 mL
- 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 (unit dose cups of 5 mL).
Inactive ingredients
Acesulfame K, butylparaben, citric acid, corn syrup, FD&C Red No. 40, flavoring, glycerin, polysorbate 80, propylene glycol, purified water, sodium benzoate, sorbitol solution, veegum and xanthan gum.
| CHILDRENS ACETAMINOPHEN
acetaminophen suspension |
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| Labeler - Pharmaceutical Associates, Inc. (044940096) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Pharmaceutical Associates, Inc. | 097630693 | MANUFACTURE(0121-1781) | |