OTC Medication Information: Acetaminophen For Children

ACETAMINOPHEN FOR CHILDREN- acetaminophen suppository
Preferred Pharmaceuticals, Inc.

Active ingredient (in each rectal suppository)

Acetaminophen 120 mg

Purposes

Pain reliever/fever reducer

Uses

temporarily

reduces fever
relieves minor aches, pains, and headache

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

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.

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)

Other information

store at 20-25° C (68-77° F) or in a cool place
tamper-evident: suppositories are individually wrapped. Do not use if printed wrapper is opened or damaged.

Inactive ingredient

hydrogenated vegetable oil

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to FeverAll® active ingredient

For Children

Acetaminophen Suppositories USP, 120 mg

Pain Reliever/Fever Reducer

Ages 3-6 years

See New Warning

12 RECTAL SUPPOSITORIES, 120 mg EACH

Acetaminophen Suppositories for Children, USP 120mg
(click image for full-size original)
ACETAMINOPHEN FOR CHILDREN
acetaminophen suppository
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-0426(NDC:45802-732)
Route of Administration RECTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN 120 mg
Inactive Ingredients
Ingredient Name Strength
COTTONSEED OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-0426-1 12 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 SUPPOSITORY in 1 BLISTER PACK This package is contained within the CARTON (68788-0426-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA070607 12/14/2010
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-0426)

Revised: 01/2018 Preferred Pharmaceuticals, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Medication Sections

Medication Information by RSS

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2019. All Rights Reserved.