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NDC 00113-0998-26 Good Sense Childrens Pain and Fever 160 mg/5mL Details
Good Sense Childrens Pain and Fever 160 mg/5mL
Good Sense Childrens Pain and Fever is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by L. Perrigo Company. 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: 00113-0998-26Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 00113-0998 |
|---|---|
| Product ID | 0113-0998_39f34cb8-b1ee-406e-93d5-fbcaf0afde1e |
| 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 | Good Sense Childrens Pain and Fever |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Acetaminophen |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SUSPENSION |
| Route | ORAL |
| Active Ingredient Strength | 160 |
| Active Ingredient Units | mg/5mL |
| Substance Name | ACETAMINOPHEN |
| Labeler Name | L. Perrigo Company |
| 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 00113-0998-26 (00113099826)
| NDC Package Code | 0113-0998-26 |
|---|---|
| Billing NDC | 00113099826 |
| Package | 1 BOTTLE in 1 CARTON (0113-0998-26) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2010-07-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 7111f326-8350-4039-ab7f-6b4bc39e73ad Details
Uses
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
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.
Do not use
- •
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- •
- if your child has ever had an allergic reaction to this product or any of its ingredients
Stop use and ask a doctor if
- •
- pain gets worse or lasts more than 5 days
- •
- fever gets worse or lasts more than 3 days
- •
- new symptoms occur
- •
- redness or swelling is present
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
Directions
- •
- this product does not contain directions or complete warnings for adult use
- •
- do not give more than directed (see overdose warning)
- •
- shake well before using
- •
- mL = milliliter; tsp = teaspoonful
- •
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- •
- remove the child protective cap and squeeze your child’s dose into the dosing cup
- •
- repeat dose every 4 hours while symptoms last
- •
- do not give more than 5 times in 24 hours
|
Weight (lb) |
Age (yr) |
Dose (mL or tsp)* |
|
under 24 |
under 2 years |
ask a doctor |
|
24-35 |
2-3 years |
5 mL (1 tsp) |
|
36-47 |
4-5 years |
7.5 mL (1 ½ tsp) |
|
48-59 |
6-8 years |
10 mL (2 tsp) |
|
60-71 |
9-10 years |
12.5 mL (2 ½ tsp) |
|
72-95 |
11 years |
15 mL (3 tsp) |
*or as directed by a doctor
Attention:
use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Other information
Inactive ingredients
anhydrous citric acid, calcium sulfate, carrageenan, FD&C red #40, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, propylparaben, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
Principal Display Panel
INGREDIENTS AND APPEARANCE
| GOOD SENSE CHILDRENS PAIN AND FEVER
acetaminophen suspension |
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| Labeler - L. Perrigo Company (006013346) |