Label: FEVERALL JR. STRENGTH- acetaminophen suppository
- NDC Code(s): 51672-2116-0, 51672-2116-2, 51672-2116-4
- Packager: Taro Pharmaceuticals U.S.A. Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 26, 2019
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each rectal suppository)
- Purposes
- Uses
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Warnings
Liver warning
This product contains acetaminophen.
Severe liver damage may occur if
- a child 6 to 12 years takes more than 5 doses in 24 hours
- an adult or child 12 years and older takes more than 6 doses in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- an adult takes 3 or more alcoholic drinks every day while using this product
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
- in children under 6 years
- 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 and ask a doctor if
- fever lasts more than 3 days (72 hours), or recurs.
- pain gets worse or lasts more than 10 days.
- new symptoms occur.
- redness or swelling is present in the painful area.
These may be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use. 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.
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Directions
- do not use more than directed
- remove wrapper
- carefully insert suppository well up into the rectum
Dosing Chart Age Dose under 6 years do not use 6 to 12 years Use 1 suppository every 4 to 6 hours. (maximum of 5 doses in 24 hours) adults and children 12 years and older Use 2 suppositories every 4 to 6 hours. (maximum of 6 doses) - Other information
- Inactive ingredients
- Questions?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 325 mg Suppository Blister Pack Carton
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INGREDIENTS AND APPEARANCE
FEVERALL JR. STRENGTH
acetaminophen suppositoryProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2116 Route of Administration RECTAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 325 mg Inactive Ingredients Ingredient Name Strength glyceryl monostearate (UNII: 230OU9XXE4) hydrogenated palm kernel oil (UNII: FM8D1RE2VP) PEG-100 stearate (UNII: YD01N1999R) polysorbate 80 (UNII: 6OZP39ZG8H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51672-2116-2 6 in 1 CARTON 12/12/2013 1 NDC:51672-2116-0 1 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:51672-2116-4 50 in 1 CARTON 12/12/2013 2 NDC:51672-2116-0 1 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018337 12/12/2013 Labeler - Taro Pharmaceuticals U.S.A. Inc. (145186370) Establishment Name Address ID/FEI Business Operations G&W NC Laboratories, Inc. 079419931 MANUFACTURE(51672-2116)
