Search by Drug Name or NDC
NDC 63187-0294-04 Childrens Silapap 160 mg/5mL Details
Childrens Silapap 160 mg/5mL
Childrens Silapap is a ORAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is ACETAMINOPHEN.
MedlinePlus Drug Summary
Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). 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: 63187-0294-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 63187-0294 |
|---|---|
| Product ID | 63187-294_c8f2d022-c0bf-4cf5-b0bf-e5b95ad93228 |
| 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 | Childrens Silapap |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | LIQUID |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | Proficient Rx LP |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | OTC MONOGRAPH NOT FINAL |
| Application Number | part343 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 63187-0294-04 (63187029404)
| NDC Package Code | 63187-294-04 |
|---|---|
| Billing NDC | 63187029404 |
| Package | 118 mL in 1 BOTTLE, PLASTIC (63187-294-04) |
| Marketing Start Date | 2018-12-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 3b1e0e31-c6a8-4c2e-aa00-67f1b6bee797 Details
SPL UNCLASSIFIED SECTION
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- •
- more than 5 doses in 24 hours, which is the maximum daily amount
- •
- with other drugs containing acetaminophen
- •
- 3 or more alcoholic drinks every day while using this product
Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Alcohol warning:If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Do not use
- •
- with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- if the user is allergic to acetaminophen or any of the inactive ingredients in this product
Directions
- •
- do not take more than directed (see overdose warning).
- •
- if needed, repeat dose every 4 hours or as directed by a doctor
- •
- do not give more than 5 doses in 24 hours
|
children under 2 yrs (under 24 lbs) |
ask a doctor |
|
children 2-3 years (24-35 lbs) |
1 teaspoonful (TSP)(5 mL) |
|
children 4-5 years (36-47 lbs) |
1 1/2 teaspoonfuls (TSP)(7.5 mL) |
|
children 6-8 years (48-59 lbs) |
2 teaspoonfuls (TSP)(10 mL) |
|
children 9-10 years (60-71 lbs) |
2 1/2 teaspoonfuls (TSP)(12.5 mL) |
|
children 11 years (72-95 lbs) |
3 teaspoonfuls (TSP)(15 mL) |
|
adults & children 12 years & older |
4 teaspoonfuls (TSP)(20 mL) |
Other information
Store at room temperature 20°-25°C (68°-77°F)
Inactive ingredients
Questions
INGREDIENTS AND APPEARANCE
| CHILDRENS SILAPAP
acetaminophen liquid |
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
|
||||||||||||||||||||
| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(63187-294) , RELABEL(63187-294) | |