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 4-5 48-59 6-8 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
NDC 69618-012-03
FRUIT FLAVORED
Acetominophen USP 80 mg
PAIN RELIEVER
FEVER REDUCER
30 CHEWABLE TABLETS
*Compare to Active Ingredient in Children's TYLENOL®
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69618-012-03 | 2021-08-09 | C162847 | 48780-1 | 9d75b9d0-b71c-f424-e053-dadaa90a57ce | ACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET |
| 69618-012-03 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-b71c-f424-e053-dadaa90a57ce | ACETAMINOPHEN USP 80 MG FRUIT CHEW TABLET |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 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 |
|---|---|
| 69618-012 | 69618-012-03 |
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 |
| CELLULOSE, MICROCRYSTALLINE | OP1R32D61U | IACT |
| D&C RED NO. 27 | 2LRS185U6K | IACT |
| STEARIC ACID | 4ELV7Z65AP | IACT |
| DEXTROSE | 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 |
|---|---|---|---|---|---|---|
| c9279bd1-bbdc-1ca8-e053-2995a90aa740 | 2707806f-8de4-4a2c-e054-00144ff8d46c | 2021-08-09 | Warnings | 2707806f-8de4-4a2c-e054-00144ff8d46c |
Adverse event summaries are temporarily unavailable. Other product information remains available.