CHILDRENS ACETAMINOPHEN- acetaminophen suspension
Pharmaceutical Associates, Inc.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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Children's Acetaminophen Oral Suspension
Alcohol Free / Aspirin Free
Uses
Temporarily:
- reduces fever
- relieves minor aches and pain due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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.
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
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
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| Weight (lbs) | 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) |
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
NDC 0121-1781-00: Case contains 100 unit dose cups of 5 mL (0121-1781-05) packaged in 10 trays of 10 unit dose cups each.
Inactive ingredients
Acesulfame K, butylparaben, citric acid, high fructose 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) | |