Drug Facts
6b598f6b-539f-47bc-a10d-492add370cfd
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Acetaminophen 160 mg
Purpose
Pain reliever/fever reducer
Medication Information
Purpose
Pain reliever/fever reducer
Description
Acetaminophen 160 mg
Uses
- temporarily reduces fever
- temporarily 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.
Directions
- this product does not contain directions or complete warnings for adult use.
- do not take more than directed (see overdose warning)
- shake well before using
- mL= milliliter
- only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
- remove cap, insert syringe into hole at top of bottle and turn upside down
- pull back syringe until filled to be prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
- If needed, repeat dose every 4 hours while syptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
| Weight (lb) | Age (year) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
Do Not Use
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Package Label
Other Information
- store between 20-25ºC (68º-77ºF)
- do not refrigerate.
- see bottom panel for lot number and expiration date
Inactive Ingredients
acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructos corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO INFANTS' TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT**
Infants' Pain Reliever
Acetaminophen 160 mg per 5 mL
Oral suspension alcohol free
- aspirin free
- alcohol free
- ibuprofen free
PAIN RELIEVER / FEVER REDUCER
Ages 2-3 years
Enhanced dosing system reduces the chance of accidental ingestion and overdose
Use Only Enclosed Syringe
CHERRY FLAVOR
fl oz (mL)
**This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, distributor of Infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141
When Using This Product,
do not exceed recommended dose (see overdose warning)
Stop Use and Ask A Doctor If
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Active Ingredient (in Each 5 Ml)
Acetaminophen 160 mg
Ask A Doctor Before Use If Your Child Has
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child Is
taking the blood thinning drug warfarin.
Structured Label Content
Uses
- temporarily reduces fever
- temporarily relieves minor aches and pains due to
- the common cold
- flu
- headache
- sore throat
- toothache
Purpose
Pain reliever/fever reducer
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.
Directions
- this product does not contain directions or complete warnings for adult use.
- do not take more than directed (see overdose warning)
- shake well before using
- mL= milliliter
- only use the enclosed syringe. Do not use any other syringe, dropper, spoon or dosing device when giving this medicine to your child
- remove cap, insert syringe into hole at top of bottle and turn upside down
- pull back syringe until filled to be prescribed level. If you pass the prescribed level, invert assembly to right side up on flat surface and simply push syringe back until you have reached the desired level. Slowly dispense the liquid into your child's mouth (towards inner cheek)
- If needed, repeat dose every 4 hours while syptoms last
- do not give more than 5 times in 24 hours
- do not give more than 5 days unless directed by a doctor
- replace cap tightly to maintain child resistance
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age
| Weight (lb) | Age (year) | Dose (mL)* |
| under 24 | under 2 years | ask a doctor |
| 24-35 | 2-3 years | 5 mL |
*or as directed by a doctor
Do Not Use (Do not use)
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Package Label
Other Information (Other information)
- store between 20-25ºC (68º-77ºF)
- do not refrigerate.
- see bottom panel for lot number and expiration date
Inactive Ingredients (Inactive ingredients)
acesulfame potassium, butylparaben, carboxymethylcellulose sodium, citric acid, FD&C red #40, flavors, glycerin, high fructos corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, xanthan gum
Questions Or Comments? (Questions or comments?)
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
COMPARE TO INFANTS' TYLENOL® ORAL SUSPENSION ACTIVE INGREDIENT**
Infants' Pain Reliever
Acetaminophen 160 mg per 5 mL
Oral suspension alcohol free
- aspirin free
- alcohol free
- ibuprofen free
PAIN RELIEVER / FEVER REDUCER
Ages 2-3 years
Enhanced dosing system reduces the chance of accidental ingestion and overdose
Use Only Enclosed Syringe
CHERRY FLAVOR
fl oz (mL)
**This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, distributor of Infants' Tylenol® Oral Suspension.
TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF PRINTED SAFETY SEAL AROUND BOTTLE IS BROKEN OR MISSING.
KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.
Distributed by McKesson Corp.,
via Strategic Sourcing Services LLC,
Memphis, TN 38141
When Using This Product, (When using this product,)
do not exceed recommended dose (see overdose warning)
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
- new symptoms occur
- redness or swelling is present
- pain gets worse or lasts more than 5 days
- fever gets worse or lasts more than 3 days
These could be signs of a serious condition.
Keep Out of Reach of Children. (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 (1-800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs or symptoms.
Active Ingredient (in Each 5 Ml) (Active ingredient (in each 5 mL))
Acetaminophen 160 mg
Ask A Doctor Before Use If Your Child Has (Ask a doctor before use if your child has)
liver disease.
Ask A Doctor Or Pharmacist Before Use If Your Child Is (Ask a doctor or pharmacist before use if your child is)
taking the blood thinning drug warfarin.
Advanced Ingredient Data
Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:03:08.618964 · Updated: 2026-03-14T23:03:02.507799