Indications and uses
temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches
temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches
■ ■ ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Repl...
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)
Purpose: Fever reducer/pain reliever
temporarily:
■ reduces fever
■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches
This product contains acetaminophen. Severe liver damage may occur if your child takes:
Liver 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. Sore throat warning
liver disease. taking the blood thinning drug warfarin.
Ask a doctor before use if your child has
Ask a doctor or pharmacist before use if your child is
■ new symptoms occur ■ redness or swelling is present ■ pain gets worse or lasts for more than 5 days ■ fever gets worse or lasts for more than 3 days.
These could be signs of serious condition.
.
Keep out of reach of children
: 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, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms. Overdose warning
■ ■ ■ find right dose on chart, if possible use weight to dose; otherwise, use age ■ use only enclosed dropper designed for use with this product, do not use any other dosing device ■ fill to dose level ■ dispense liquid slowly into child's mouth, toward inner cheek ■ may be given alone or mixed with formula, milk, juice etc. ■ If needed, repeat dose every 4 hours ■ do not give more than 5 times in 24 hours ■ Replace dropper tightly to maintain child resistance
this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
| Weight (lb) | Age (yr)
| Dose (mL) |
| under 24
| under 2 years
| ask a doctor
|
| 24-35
| 2-3 years
| 1.6 mL (0.8 + 0.8 mL)
|
For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb. Store between 20° - 25°C (68° - 77°F)
Other information
citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.
1-888-974-5279
Manufactured by:
Silarx Pharmaceuticals, Inc. 1033 Stoneleigh Ave. Carmel , NY 10512
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 238159 | acetaminophen 500 MG in 5 mL Oral Solution | PSN | 2 |
| 238159 | acetaminophen 100 MG/ML Oral Solution | SCD | 2 |
| 238159 | acetaminophen 500 MG per 5 ML Oral Solution | SY | 2 |
| 238159 | acetaminophen 80 MG per 0.8 ML Oral Solution | SY | 2 |
| 238159 | APAP 100 MG/ML Oral Solution | SY | 2 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 17856-0145-3 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-ce38-f424-e053-dadaa90a57ce | Infant's Silapap Drops |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 17856-0145-3 | Infants Silapap | 1 mL in 1 SYRINGE | SOLUTION/ DROPS | 1 | 2 |
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 17856-0145 | INFANTS SILAPAP (ACETAMINOPHEN) SOLUTION/ DROPS [ATLANTIC BIOLOGICALS CORPS] | 2 | Legacy NDC, 1 package rows | 20160505_9dacc307-0f84-4aa6-a0e6-cb99c6669bc1.zip |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54838-145-15 | ML - Milliliter | 54838-145 | 3f4791e7-3734-44b4-bdec-eed360a160c4 | 1 | 2012-07-24 |
| 54838-145-30 | ML - Milliliter | 54838-145 | cf331cd0-d733-4230-b042-1ae69e6529e6 | 1 | 2012-07-24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 17856-0145 | 17856-0145-3 |
| 54838-145 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Acetaminophen | 362O9ITL9D | ACTIB |
| anhydrous citric acid | XF417D3PSL | IACT |
| FD&C yellow no. 6 | H77VEI93A8 | IACT |
| methylparaben | A2I8C7HI9T | IACT |
| SACCHARIN SODIUM | SB8ZUX40TY | IACT |
| sodium benzoate | OJ245FE5EU | IACT |
| sodium citrate | 1Q73Q2JULR | IACT |
| propylene glycol | 6DC9Q167V3 | IACT |
| water | 059QF0KO0R | 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 |
|---|---|---|---|---|---|---|
| 393e4344-81b1-42b1-9ade-a9abee8975f7 | 9dacc307-0f84-4aa6-a0e6-cb99c6669bc1 | 2016-05-05 | Warnings | 393e4344-81b1-42b1-9ade-a9abee8975f7 9dacc307-0f84-4aa6-a0e6-cb99c6669bc1 |
Adverse event summaries are temporarily unavailable. Other product information remains available.