Infant's Silapap Drops

Manufacturer: Lannett Company, Inc.
Effective date: 2014-06-27
Label type: HUMAN OTC DRUG LABEL
Version: 16
Source: legacy-cache
Hydrated at: 2026-08-02 00:33:01

Label at a glance#

ProductInfants Silapap

Active ingredientACETAMINOPHEN

Label structure12 sections

Indications and uses

temporarily: ■ reduces fever ■ relieves minor aches and pains due to: ■the common cold ■flu ■toothaches ■sore throat ■headaches

Dosage and administration

■ this product does not contain directions or complete warnings for adult use ■ do not give more than directed (see 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...

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-888-974-5279

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

OTC - PURPOSE SECTION

Purpose: Fever reducer/pain reliever

Uses

INDICATIONS & USAGE SECTION

temporarily:

■ reduces fever

■ relieves minor aches and pains due to:
■the common cold ■flu ■toothaches ■sore throat ■headaches

Warnings

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if your child takes:

more than 5 doses in 24 hours, which is the maximum daily amount

with other drugs containing acetaminophen

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.

Do not use

OTC - DO NOT USE SECTION

with any other product containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if your child is allergic to acetaminophen or any of the inactive ingredients in this product

Ask a doctor before use if your child has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product

OTC - WHEN USING SECTION

do not exceed recommended dosage. (see overdose warning)

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

■ this product does not contain directions or complete warnings for adult use
■ do not give more than directed (see 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

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.

Other information
Store between 20° - 25°C (68° - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.

Comments

OTC - QUESTIONS SECTION

1-888-974-5279

Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave.
Carmel , NY 10512

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Acetaminophen	ACTIVE INGREDIENT	362O9ITL9D	14
Acetaminophen	ACTIVE MOIETY	362O9ITL9D	14
anhydrous citric acid	INACTIVE INGREDIENT	XF417D3PSL	14
FD&C yellow no. 6	INACTIVE INGREDIENT	H77VEI93A8	14
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	14
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	14
saccharin sodium dihydrate	INACTIVE INGREDIENT	SB8ZUX40TY	14
sodium benzoate	INACTIVE INGREDIENT	OJ245FE5EU	14
sodium citrate	INACTIVE INGREDIENT	1Q73Q2JULR	14
water	INACTIVE INGREDIENT	059QF0KO0R	14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

Infants Silapap
Acetaminophen
ANHYDROUS CITRIC ACID
FD&C YELLOW NO. 6
METHYLPARABEN
SACCHARIN SODIUM
SODIUM BENZOATE
SODIUM CITRATE
PROPYLENE GLYCOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54838-145	54838-145-15, 54838-145-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 324 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	FILM / SUBLINGUAL	0.03 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CONCENTRATE / ORAL	0.03 mg/5ml		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	POWDER / ORAL	20 mg		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	SPONGE / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EXTENDED RELEASE / ORAL		312 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / SUBCUTANEOUS		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CAPSULE / ORAL	8.5 mg		Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SYRUP / ORAL		24 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	POWDER, FOR SUSPENSION / ORAL		160 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	LOZENGE / TRANSMUCOSAL		44 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SHAMPOO / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SOLUTION / TOPICAL	0.1 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	SOLUTION / ORAL		665 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	GEL / TOPICAL		3 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SHAMPOO / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	INJECTION, SOLUTION / INTRAMUSCULAR	4.8 %w/v		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	GEL / DENTAL	0.08 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	PASTE / ORAL		28 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	POWDER, FOR SOLUTION / ORAL		199 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / RECTAL		90400 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	CREAM / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 35 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	JELLY / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SOLUTION, CONCENTRATE / INTRAVENOUS		60 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	SUSPENSION / ORAL		11 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	AEROSOL, METERED / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / ORAL		3 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	FILM / BUCCAL		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SYRUP / ORAL		80 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
sodium benzoate	SODIUM BENZOATE	OJ245FE5EU	SUSPENSION / ORAL		320 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM, EXTENDED RELEASE / TRANSDERMAL	58.13 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	GEL / TOPICAL	NA		Exact identifier — unii candidate 34 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
saccharin sodium dihydrate	SACCHARIN SODIUM	SB8ZUX40TY	PASTE / DENTAL	0.3 %w/w		Exact identifier — unii candidate 34 equally ranked IID candidates
FD&C yellow no. 6	FD&C YELLOW NO. 6	H77VEI93A8	CAPSULE, LIQUID FILLED / ORAL		1 mg	Exact identifier — unii candidate 34 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	SYRUP / ORAL		268 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
anhydrous citric acid	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM, AUGMENTED / TOPICAL	8 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates

openFDA label cross-check#

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
a9d64daf-cd20-4ae6-8d6f-8dfcf3792361			4c4ae7af-eacd-4b15-860c-d08305fce8e4	2014-06-27	Warnings	Exact identifier spl set id: 4c4ae7af-eacd-4b15-860c-d08305fce8e4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.