Drugplain

Feverall Infants 80 mg/1

Acetaminophen · SUPPOSITORY · Sun Pharmaceutical Industries, Inc.

No Recall HistoryCurrently in Shortage
Plain English

Feverall Infants is a suppository containing acetaminophen at 80 mg/1, taken rectal. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Feverall Infants
Generic Name
Acetaminophen
NDC Code (Product)
51672-2114
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
80 mg/1
Dosage Form
SUPPOSITORY
Route
RECTAL
Marketing Status
Application #
NDA018337
Marketing Start
12/12/2013

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use22,390 reports
fatigue20,440 reports
drug ineffective18,200 reports
pain18,112 reports
nausea17,648 reports
headache16,720 reports
toxicity to various agents15,586 reports
dyspnoea14,583 reports
arthralgia14,311 reports
pyrexia14,287 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 6 months Do not use unless directed by a doctor 6 to 11 months Use 1 suppository every 6 hours (maximum of 4 doses in 24 hours) 12 to 36 months 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 4 doses in 24 hours, which is the maximum daily amount for ages 6 to 11 months more than 5 doses in 24 hours, which is the maximum daily amount for ages 12 to 36 months 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 the child has liver disease. the 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 3 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 Po

Frequently Asked Questions

What is Feverall Infants used for?

Feverall Infants contains Acetaminophen. It is a suppository taken rectal. Consult your doctor for specific uses.

Is Feverall Infants a controlled substance?

Feverall Infants is not classified as a controlled substance by the DEA.

What is the generic name for Feverall Infants?

The generic name for Feverall Infants is Acetaminophen. There are 12 other brand versions of Acetaminophen.

What is the NDC code for Feverall Infants 80 mg/1?

The NDC (National Drug Code) for Feverall Infants 80 mg/1 is 51672-2114, listed by Sun Pharmaceutical Industries, Inc..