Label: FEVERALL INFANTS- acetaminophen suppository
- NDC Code(s): 0472-1200-06, 0472-1200-50
- Packager: Actavis Mid Atlantic LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated August 22, 2013
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
Acetaminophen, USP 80 mgClose
Pain reliever/fever reducerClose
- reduces fever
- relieves minor aches, pains, and headache
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
If a skin reaction occurs, stop use and seek medical help right away.
For rectal use onlyClose
- 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.Close
- 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.Close
- 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)
- store at 2º-27ºC (35º-80ºF)
- do not use if imprinted suppository wrapper is opened or damaged
- INACTIVE INGREDIENTS
Glycerol monostearate, hydrogenated vegetable oil, polyoxyethylene stearate, polysorbate 80Close
1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Ages 6-36 months
Pain reliever/fever reducer
6 Rectal Suppositories
80 mg each
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0472-1200 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) POLYSORBATE 80 (UNII: 6OZP39ZG8H) HYDROGENATED PALM KERNEL OIL (UNII: FM8D1RE2VP) PEG-100 STEARATE (UNII: YD01N1999R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0472-1200-06 6 in 1 BOX 2 NDC:0472-1200-50 50 in 1 BOX Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018337 04/01/1980 Labeler - Actavis Mid Atlantic LLC (809515898) Establishment Name Address ID/FEI Business Operations Actavis Mid Atlantic LLC 809515898 ANALYSIS(0472-1200) , LABEL(0472-1200) , MANUFACTURE(0472-1200) , PACK(0472-1200)