Hy-Vee, Inc. Infants’ Pain Relief Drug Facts
pain relief by
Drug Labeling and Warnings
pain relief by is a Otc medication manufactured, distributed, or labeled by HyVee Inc. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
PAIN RELIEF INFANTS- acetaminophen suspension
HyVee Inc
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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Hy-Vee, Inc. Infants’ Pain Relief Drug Facts
Uses
temporarily:
- reduces fever
- relieves minor aches and pains due to:
- the common cold
- flu
- headache
- sore throat
- toothache
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. If possible, use weight to dose; otherwise, use age.
- push air out of syringe. Insert syringe tip into bottle opening.
- flip bottle upside down. Pull yellow part of syringe to the first dose line and then push product back into bottle.
- pull yellow part of syringe until it reaches and stays at the correct dose
- dispense liquid slowly into child’s mouth, toward inner cheek
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
- replace cap tightly to maintain child resistance
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Dosing Chart |
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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
COMPARE TO the Active Ingredient of Infants’ Tylenol® Oral Suspension
See New Warnings
For Ages 2 to 3 Years
Infants’ Pain Relief
Suspension Liquid
Acetaminophen 160 mg per 5 mL
Pain Reliever / Fever Reducer
Grape Flavor
Fast, Effective Relief of Infants’ Pain and Fever
Aspirin Free
Ibuprofen Free
Alcohol Free
Use only with enclosed syringe.
See side panel for more information.
2 FL OZ (60 mL)
Pediatrician Preferred Dosing System
| PAIN RELIEF
INFANTS
acetaminophen suspension |
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| Labeler - HyVee Inc (006925671) |