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
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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 DEA Schedule 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)