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NDC 70000-0472-01 leader infants pain and fever 160 mg/5mL Details
leader infants pain and fever 160 mg/5mL
leader infants pain and fever is a ORAL SUSPENSION in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health 110, LLC. dba Leader. 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: 70000-0472-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Acetaminophen
Product Information
| NDC | 70000-0472 |
|---|---|
| Product ID | 70000-0472_1f3eb8f8-a02a-48b7-9b8c-0811f0a29331 |
| Associated GPIs | 64200010001840 |
| GCN Sequence Number | 016947 |
| GCN Sequence Number Description | acetaminophen ORAL SUSP 160 MG/5ML ORAL |
| HIC3 | H3E |
| HIC3 Description | ANALGESIC/ANTIPYRETICS,NON-SALICYLATE |
| GCN | 26911 |
| HICL Sequence Number | 001866 |
| HICL Sequence Number Description | ACETAMINOPHEN |
| Brand/Generic | Generic |
| Proprietary Name | leader infants 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 | Cardinal Health 110, LLC. dba Leader |
| 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 70000-0472-01 (70000047201)
| NDC Package Code | 70000-0472-1 |
|---|---|
| Billing NDC | 70000047201 |
| Package | 1 BOTTLE in 1 CARTON (70000-0472-1) / 59 mL in 1 BOTTLE |
| Marketing Start Date | 2019-03-12 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.0391 |
| Pricing Unit | ML |
| Effective Date | 2024-01-17 |
| NDC Description | INFANT PAIN-FEVER 160 MG/5 ML |
| Pharmacy Type Indicator | C/I |
| OTC | Y |
| Explanation Code | 4, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL fb6566ed-8fd3-4242-81ac-383a6a5a4fbe 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
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- 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
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- mL = milliliter
- •
- find right dose on chart. If possible, use weight to dose; otherwise, use age.
- •
- push air out of syringe. Insert syringe tip into bottle opening.
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- flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
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- pull yellow part of syringe until it reaches and stays at the correct dose
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- dispense liquid slowly into child’s mouth, toward inner cheek
- •
- repeat dose every 4 hours while symptoms last
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- do not give more than 5 times in 24 hours
- •
- replace cap tightly to maintain child resistance
|
Dosing Chart |
||
|
Weight (lb) |
Age (yr) |
Dose (mL)* |
|
under 24 |
under 2 years |
ask a doctor |
|
24-35 |
2-3 years |
5 mL |
* or as directed by a doctor
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.
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
Package/Label Principal Display Panel
Infants’ Pain & Fever
Acetaminophen 160 mg per 5 mL
Oral Suspension
Pain Reliever
Fever Reducer
Grape Flavor
COMPARE TO INFANTS’ TYLENOL® ORAL SUSPENSION active ingredient
For Children
Alcohol-Free
Aspirin-Free
Ibuprofen-Free
100% Money Back Guarantee
2 FL OZ (59 mL)
USE ONLY WITH ENCLOSED SYRINGE.
SEE SIDE PANEL FOR MORE INFORMATION.
PEDIATRICIAN PREFERRED DOSING SYSTEM.
INGREDIENTS AND APPEARANCE
| LEADER INFANTS PAIN AND FEVER
acetaminophen suspension |
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| Labeler - Cardinal Health 110, LLC. dba Leader (063997360) |