Label: FEVER REDUCING CHILDRENS- acetaminophen suppository
- NDC Code(s): 59779-579-53
- Packager: CVS Pharmacy
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated 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 (in each rectal suppository)
Acetaminophen 120 mgClose
Pain reliever/fever reducerClose
- reduces fever
- relieves minor aches, pains, and headache
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
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
- your child has liver disease
- your 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. (1-800-222-1222) Quick medical attention is critical in case of overdose for adults and for children even if you do not notice any signs or symptoms.
- 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 a suppository every 4 to 6 hours (maximum of 5 doses in 24 hours)
- Other information
- tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.
- store at 20°-25°C (68°-77°F) or in a cool place
- Inactive ingredients
hydrogenated vegetable oilClose
- Questions or comments?
- Principal Display Panel
Compare to the active ingredient in FeverAll®
See New Warnings Information
FEVER REDUCING SUPPOSITORIES
ACETAMINOPHEN SUPPOSITORIES 120 mg
Pain reliever / Fever reducer
Read and Keep Carton for New Liver Warning
120 mg EACH
Fever Reducing Suppositories Carton Image 1
Fever Reducing Suppositories Carton Image 2
- INGREDIENTS AND APPEARANCE
FEVER REDUCING CHILDRENS
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:59779-579 Route of Administration RECTAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-579-53 2 in 1 CARTON 1 6 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA070607 01/21/2010 Labeler - CVS Pharmacy (062312574)