Childrens Acetaminophen Acetaminophen Acetaminophen Acetaminophen acesulfame potassium Butylparaben Citric Acid Monohydrate corn syrup FD&C Red No. 40 glycerin Polysorbate 80 Propylene Glycol Water Sodium Benzoate sorbitol Magnesium Aluminum Silicate Xanthan Gum
Drug Facts
Composition & Profile
Identifiers & Packaging
PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-1781-05 C HILDREN'S A CETAMINOPHEN O RAL S USPENSION 160 mg/5 mL Alcohol Free / Aspirin Free SHAKE WELL FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC. Greenville, SC 29605 SEE INSERT A17810501 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
- PRINCIPAL DISPLAY PANEL - 5 mL Cup Label Delivers 5 mL NDC 0121-1781-05 C HILDREN'S A CETAMINOPHEN O RAL S USPENSION 160 mg/5 mL Alcohol Free / Aspirin Free SHAKE WELL FOR INSTITUTIONAL USE ONLY PHARMACEUTICAL ASSOCIATES, INC. Greenville, SC 29605 SEE INSERT A17810501 PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
Overview
Uses temporarily: reduces fever relieves minor aches and pain due to: the common cold flu headache sore throat toothache
Indications & Usage
Uses temporarily: reduces fever relieves minor aches and pain due to: the common cold flu headache sore throat toothache
Dosage & Administration
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) or as directed by a doctor 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 & Precautions
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 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
Purpose
Purpose pain reliever/fever reducer
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product
When Using
When using this product, do not exceed the recommended dose (see overdose warning)
Stop Use & Ask a Doctor
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 Reach of Children
Keep out of the reach of children.
Storage & Handling
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).
Questions
Questions or comments? Call 1-800-845-8210. You may also report serious side effects to this phone number.
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