do not take more than directed (see overdose warning). if needed, repeat dose every 4 hours or as directed by a doctor do not give more than 5 doses in 24 hours children under 2 yrs (under 24 lbs) ask a doctor children 2-3 years (24-35 lbs) 1 teaspoonful (TSP)(5 mL) children 4-5 years (36-47 lbs) 1 1/2 teaspoonfuls (TSP)(7.5 mL) children 6-8 years (48-59 lbs) 2 teaspoonfuls (TSP)(10 mL) children 9-10 years (60-71 ...
Active Ingredient: Acetaminophen 160 mg (in each 5 mL (TSP))
Purpose: Pain reliever/fever reducer
Uses To reduce fever and for the temporary relief of minor aches and pains due to:
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
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.
Alcohol warning:If the user consumes 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Do not use
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center (1800-222-1222) right away. Quick medical attention is critical even if you do not notice any signs of symptoms.
| children under 2 yrs (under 24 lbs)
| ask a doctor
|
| children 2-3 years (24-35 lbs)
| 1 teaspoonful (TSP)(5 mL)
|
| children 4-5 years (36-47 lbs)
| 1 1/2 teaspoonfuls (TSP)(7.5 mL)
|
| children 6-8 years (48-59 lbs)
| 2 teaspoonfuls (TSP)(10 mL)
|
| children 9-10 years (60-71 lbs)
| 2 1/2 teaspoonfuls (TSP)(12.5 mL)
|
| children 11 years (72-95 lbs)
| 3 teaspoonfuls (TSP)(15 mL)
|
| adults & children 12 years & older
| 4 teaspoonfuls (TSP)(20 mL)
|
Other information
Store at room temperature 20°-25°C (68°-77°F)
citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.
888-974-5279
This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol
®.
Manufactured by:
Silarx Pharmaceuticals, Inc
1033 Stoneleigh Ave.
Carmel, NY 10512
USA
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4052-4 | 2024-07-18 | C162847 | 48780-1 | ba0f9c33-2a97-a910-e053-dadaa90a0b85 | Children's Silapap Liquid |
| 68071-4052-4 | 2023-01-30 | C162847 | 48780-1 | ba0f9c33-2a97-a910-e053-dadaa90a0b85 | Children's Silapap Liquid |
| 68071-4052-4 | 2021-02-12 | C162847 | 48780-1 | ba0f9c33-2a97-a910-e053-dadaa90a0b85 | Children's Silapap Liquid |
| 68071-4052-4 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-2a97-a910-e053-dadaa90a0b85 | Children's Silapap Liquid |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54838-144-40 | ML - Milliliter | 54838-144 | e59a7e7e-4ebe-41a6-ab02-231dbfdc8fd9 | 1 | 2012-07-24 |
| 54838-144-70 | ML - Milliliter | 54838-144 | 8d2545d1-410f-4db7-9249-6bd1ee3191c3 | 1 | 2012-07-24 |
| 54838-144-80 | ML - Milliliter | 54838-144 | 2aca2f2c-02d1-4c54-b6d3-9fbfc7e8b498 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 68071-4052 | 68071-4052-4 |
| 54838-144 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ANHYDROUS CITRIC ACID | XF417D3PSL | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SACCHARIN | FST467XS7D | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| WATER | 059QF0KO0R | IACT |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
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 |
|---|---|---|---|---|---|---|
| 1d8dceca-4934-00c1-e063-6294a90add50 | 56e70f5e-5ebc-1922-e054-00144ff88e88 | 2024-07-18 | Warnings | 56e70f5e-5ebc-1922-e054-00144ff88e88 |
Adverse event summaries are temporarily unavailable. Other product information remains available.