Indications and uses
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
temporarily reduces fever temporarily relieves minor aches and pains due to: the common cold flu headache sore throat toothache
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 until it snaps into place and turn upside down pull back syr...
Acetaminophen 160 mg
Pain reliever/fever reducer
Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:
Allergy alert: Acetaminophen may cause severe skin reactions. symptoms may include:
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.
liver disease.
taking the blood thinning drug warfarin.
do not exceed recommended dose (see overdose warning)
These could be signs of a serious condition.
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.
| Weight (lb) | Age (year) | Dose (mL) |
| under 24 | under 2 | ask a doctor |
| 24-35 | 2-3 | 5 mL |
butylparaben, carboxymethylcellulose sodium, citric acid, flavors, glycerin, high fructose corn syrup, microcrystalline cellulose, propylene glycol, purfied water, sodium benzoate, sorbitol, sucralose, xanthan gum
Call 1-877-753-3935 MOnday-Friday 9AM-5PM EST
Compare to the active ingredient in Infants' Tylenol® Oral Suspension**
Infants' Pain and Fever
Acetaminophen 160 mg per 5 mL
oral suspension
pain reliever / fever reducer
dye free
for ages 2-3 years
alcohol free
aspirin free
ibuprofen free
Cherry flavor
Use only enclosed syringe
FL OZ (mL)
**This product is not manufactured or distributed by McNeil Consumer Healthcare, 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.
Manufactured by:
PL Developments
11865 S Alameda St
Lynwood, CA 90262
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 49580-0322-2 | 2023-05-17 | C162847 | 48780-1 | f386c649-c878-0266-e053-dadaa90a7c1a | Drug Facts |
| 49580-0322-2 | 2023-01-30 | C162847 | 48780-1 | f386c649-c878-0266-e053-dadaa90a7c1a | Drug Facts |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 49580-0322 | 49580-0322-2 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| BUTYLPARABEN | 3QPI1U3FV8 | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HIGH FRUCTOSE CORN SYRUP | XY6UN3QB6S | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SORBITOL | 506T60A25R | IACT |
| XANTHAN GUM | TTV12P4NEE | IACT |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| SUCRALOSE | 96K6UQ3ZD4 | IACT |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 69a29813-8f72-42aa-a2bb-8a10d49568b6 | 9f2f2ea1-0fde-462c-ba6c-a5201f814e35 | 2023-05-17 | Warnings | 69a29813-8f72-42aa-a2bb-8a10d49568b6 9f2f2ea1-0fde-462c-ba6c-a5201f814e35 |
Adverse event summaries are temporarily unavailable. Other product information remains available.