Feverall Childrens ACETAMINOPHEN SUN PHARMACEUTICAL INDUSTRIES, INC. FDA Approved Uses temporarily reduces fever relieves minor aches, pains, and headache
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Substance Acetaminophen
Route
RECTAL
Applications
NDA018337

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each rectal suppository) Acetaminophen USP 120 mg
Inactive Ingredients
Inactive ingredients glycerol monostearate hydrogenated vegetable oil polyoxyethylene stearate polysorbate 80
Strengths
120 mg
Treats Conditions
Uses Temporarily Reduces Fever Relieves Minor Aches Pains And Headache

Identifiers & Packaging

Container Type BOX
UPC
0351672211523
UNII
362O9ITL9D
Packaging

PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton NDC 51672-2115-2 RECTAL SUPPOSITORY* *actual size Doctor Recommended Pain Reliever/Fever Reducer No Parabens or Any Other Preservatives No Artificial Colors CHILDREN'S ages 3-6 years FeverAll ® ACETAMINOPHEN SUPPOSITORIES Pain Reliever/Fever Reducer 6 Rectal Suppositories 120 mg each PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton

Package Descriptions
  • PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton NDC 51672-2115-2 RECTAL SUPPOSITORY* *actual size Doctor Recommended Pain Reliever/Fever Reducer No Parabens or Any Other Preservatives No Artificial Colors CHILDREN'S ages 3-6 years FeverAll ® ACETAMINOPHEN SUPPOSITORIES Pain Reliever/Fever Reducer 6 Rectal Suppositories 120 mg each PRINCIPAL DISPLAY PANEL - 120 mg Suppository Blister Pack Carton

Overview

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

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 & 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 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 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. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
Purpose

Purposes Pain reliever/fever reducer

Do Not Use

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.

Stop Use & Ask a Doctor

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

Keep out of reach of children. If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information store at 2°-27°C (35°-80°F) do not use if imprinted suppository wrapper is opened or damaged

Questions

Questions? call 1-866-923-4914


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