Indications and uses
temporarily reduces fever and relieves minor aches and pains caused by • headache • the common cold • flu • toothache • sore throat
temporarily reduces fever and relieves minor aches and pains caused by • headache • the common cold • flu • toothache • sore throat
• this product does not contain directions or complete warnings for adult use • do not take more than directed (see Overdose warning) • find correct dose on chart below • if possible, use weight to dose, otherwise use age • chew tablets before swallowing • give dose every 4 hours while symptoms last • do not give more than 5 doses in 24 hours Weight (pounds) Age (years) Dose (tablets) 72-95 11-12 4-6 60-71 9-10 4-...
• store at room temperature 15°-30°C (59°-86°F)
Drug Facts
Acetaminophen USP, 80 mg
Pain Reliever/Fever Reducer
temporarily reduces fever and relieves minor aches and pains caused by
Liver warning: This product contains acetaminophen. Severe liver damage may occur if the 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, lasts for more than 2 days or 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 wheater a drug contains acetaminophen, ask a doctor or pharmacist.
Ask a doctor before use if the child has liver disease
Ask a doctor or pharmacist before use if the child is taking the blood thinning drug warfarin
Drug Facts continued on back of label
Stop use and ask a doctor if
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 right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Weight (pounds) | Age (years) | Dose (tablets) |
72-95 | 11-12 | 4-6 |
60-71 | 9-10 | 4-5 |
48-59 | 6-8 | 4 |
36-47 | 4-5 | 3 |
24-35 | 2-3 | 2 |
under 24 | under 2 | ask a doctor |
aspartame, compressible sugar, D&C red #27 (Al-lake), dextrose, FD&C yellow #6 (Al-lake), flavors, magnesium stearate, microcrystalline cellulose, stearic acid
call 516-341-0666 8:30 am - 4:30 pm ET, Monday - Friday
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320
NDC 63187-944-30
FRUIT FLAVORED
Acetominophen USP 80 mg
PAIN RELIEVER
FEVER REDUCER
30 CHEWABLE TABLETS
*Compare to Active Ingredient in Children's TYLENOL®
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 63187-944-30 | EA - Each | 63187-944 | 830c1f32-65a6-40d5-85f2-fc0a9bc12633 | 1 | 2018-02-20 |
| 69618-012-03 | EA - Each | 69618-012 | e1cdd41c-08b3-4c9e-952f-5a9f05b019ce | 1 | 2016-03-04 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 63187-944 | 63187-944-20, 63187-944-30, 63187-944-40, 63187-944-50, 63187-944-60 |
| 69618-012 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| ASPARTAME | Z0H242BBR1 | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| MICROCRYSTALLINE CELLULOSE | OP1R32D61U | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| DEXTROSE, UNSPECIFIED FORM | IY9XDZ35W2 | IACT |
| SUCROSE | C151H8M554 | 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 |
|---|---|---|---|---|---|---|
| 7d68fbbc-1039-46f5-8f4b-ce60dc16ac30 | 7a5f9416-a11d-45fb-bc1a-bd2991d1c10e | 2022-10-01 | Warnings | 7a5f9416-a11d-45fb-bc1a-bd2991d1c10e |
Adverse event summaries are temporarily unavailable. Other product information remains available.