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NDC 63629-8240-01 Feverall 325 mg/1 Details
Feverall 325 mg/1
Feverall is a RECTAL SUPPOSITORY in the HUMAN OTC DRUG category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen rectal is used to relieve mild to moderate pain from headaches or muscle aches and to reduce a fever. Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
Related Packages: 63629-8240-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen Rectal
Product Information
NDC | 63629-8240 |
---|---|
Product ID | 63629-8240_302b4f3b-6f8a-410d-8e3d-19c72be2276b |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Feverall |
Proprietary Name Suffix | Jr. Strength |
Non-Proprietary Name | Acetaminophen |
Product Type | HUMAN OTC DRUG |
Dosage Form | SUPPOSITORY |
Route | RECTAL |
Active Ingredient Strength | 325 |
Active Ingredient Units | mg/1 |
Substance Name | ACETAMINOPHEN |
Labeler Name | Bryant Ranch Prepack |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | NDA |
Application Number | NDA018337 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 63629-8240-01 (63629824001)
NDC Package Code | 63629-8240-1 |
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Billing NDC | 63629824001 |
Package | 12 SUPPOSITORY in 1 BOTTLE (63629-8240-1) |
Marketing Start Date | 2019-09-12 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0 Details
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 everyday while using this product
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
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.
Directions
- remove wrapper
- do not use more than directed
- carefully insert suppository well up into the rectum
Dosing Chart | |
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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
INGREDIENTS AND APPEARANCE
FEVERALL
JR. STRENGTH
acetaminophen suppository |
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Labeler - Bryant Ranch Prepack (171714327) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Bryant Ranch Prepack | 171714327 | REPACK(63629-8240) , RELABEL(63629-8240) |
Revised: 10/2019
Document Id: 302b4f3b-6f8a-410d-8e3d-19c72be2276b
Set id: 3f2cb4d8-64f8-42cd-91df-cd97480ee5f0
Version: 1
Effective Time: 20191001