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NDC 71205-0263-04 Childrens Acetaminophen 160 mg/5mL Details
Childrens Acetaminophen 160 mg/5mL
Childrens Acetaminophen is a ORAL SUSPENSION 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: 71205-0263-04Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 71205-0263 |
|---|---|
| Product ID | 71205-263_4119daf0-efea-4ec9-869d-55d9aaf09d0e |
| Associated GPIs | 64200010001840 |
| 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 Acetaminophen |
| 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 | 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 71205-0263-04 (71205026304)
| NDC Package Code | 71205-263-04 |
|---|---|
| Billing NDC | 71205026304 |
| Package | 1 BOTTLE in 1 CARTON (71205-263-04) / 118 mL in 1 BOTTLE |
| Marketing Start Date | 2019-05-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 57e4820c-b4eb-442e-9c49-93eedfbc5e5e 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
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.
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
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
- •
- find right dose on chart below. 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)* |
|
under 24 |
under 2 years |
ask a doctor |
|
24-35 |
2-3 years |
5 mL |
|
36-47 |
4-5 years |
7.5 mL |
|
48-59 |
6-8 years |
10 mL |
|
60-71 |
9-10 years |
12.5 mL |
|
72-95 |
11 years |
15 mL |
*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, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
Principal Display Panel
Compare to Children’s Tylenol® Oral Suspension active ingredient
Children’s
Acetaminophen
160 mg per 5 mL
Pain Reliever – Fever Reducer
Oral Suspension
For Ages 2 to 11 Years
Aspirin Free
Ibuprofen Free
Alcohol Free
Dosage Cup Included
Grape Flavor
4 FL OZ (118 mL)
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
INGREDIENTS AND APPEARANCE
| CHILDRENS ACETAMINOPHEN
acetaminophen suspension |
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| Labeler - Proficient Rx LP (079196022) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Proficient Rx LP | 079196022 | REPACK(71205-263) , RELABEL(71205-263) | |