acetaminophen for children 120 mg/1

Acetaminophen · SUPPOSITORY · NuCare Pharmaceuticals,Inc.

No Recall HistoryCurrently in Shortage

Plain English

acetaminophen for children is a suppository containing acetaminophen at 120 mg/1, taken rectal. Manufactured by NuCare Pharmaceuticals,Inc..

Key Facts

Brand Name: acetaminophen for children
Generic Name: Acetaminophen
NDC Code (Product): 68071-4172
Manufacturer: NuCare Pharmaceuticals,Inc.
Strength: 120 mg/1
Dosage Form: SUPPOSITORY
Route: RECTAL
Marketing Status
Application #: ANDA070607
Marketing Start: 12/14/2010

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use22,386 reports

fatigue20,433 reports

drug ineffective18,154 reports

pain18,105 reports

nausea17,623 reports

headache16,713 reports

toxicity to various agents15,538 reports

dyspnoea14,576 reports

arthralgia14,308 reports

pyrexia14,269 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses temporarily • reduces fever • relieves minor aches, pains, and headache

Dosage & Administration

Directions • this product does not contain directions or warnings for adult use • do not use more than directed • remove wrapper • carefully insert suppository well up into the rectum Dosing Chart Age Dose under 3 years Do not use unless directed by a doctor 3 to 6 years Use 1 suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)

Warnings

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 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. For rectal use only Do not use • if you are allergic to acetaminophen • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. Ask a doctor before use if • your child has liver disease • your child is taking the blood thinning drug warfarin Stop use and ask a doctor if • fever lasts more than 3 days (72 hours), or recurs. • pain lasts more than 5 days or gets worse. • new symptoms occur. • redness or swelling is present in the painful area. These may be signs of a serious condition. Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical in c…

Frequently Asked Questions

What is acetaminophen for children used for?

acetaminophen for children contains Acetaminophen. It is a suppository taken rectal. Consult your doctor for specific uses.

Is acetaminophen for children a controlled substance?

acetaminophen for children is not classified as a controlled substance by the DEA.

What is the generic name for acetaminophen for children?

The generic name for acetaminophen for children is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for acetaminophen for children 120 mg/1?

The NDC (National Drug Code) for acetaminophen for children 120 mg/1 is 68071-4172, listed by NuCare Pharmaceuticals,Inc..

Product NDC

68071-4172

Package NDC

68071-4172-6

Other Acetaminophen Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)