Label: INFANTS SILAPAP - acetaminophen solution/ drops
- NDC Code(s): 54838-145-15, 54838-145-30
- Packager: Silarx Pharmaceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENT
Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)Close
Purpose: Fever reducer/pain relieverClose
■ reduces fever
■ relieves minor aches and pains due to:Close
■the common cold ■flu ■toothaches ■sore throat ■headaches
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.Close
- Do not use
- 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.Close
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.
- When using this product
- do not exceed recommended dosage. (see overdose warning)
- Stop use and ask a doctor if
■ 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
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.Close
■ 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
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.Close
Store between 20° - 25°C (68° - 77°F)
- Inactive ingredients
citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.Close
Silarx Pharmaceuticals, Inc.Close
1033 Stoneleigh Ave.
Carmel , NY 10512
- INGREDIENTS AND APPEARANCE
acetaminophen solution/ drops
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-145 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 80 mg in 0.8 mL Inactive Ingredients Ingredient Name Strength anhydrous citric acid (UNII: XF417D3PSL) FD&C yellow no. 6 (UNII: H77VEI93A8) methylparaben (UNII: A2I8C7HI9T) saccharin sodium dihydrate (UNII: SB8ZUX40TY) sodium benzoate (UNII: OJ245FE5EU) sodium citrate (UNII: 1Q73Q2JULR) propylene glycol (UNII: 6DC9Q167V3) water (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (wild cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54838-145-15 15 mL in 1 BOTTLE, DROPPER 2 NDC:54838-145-30 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 04/01/1997 Labeler - Silarx Pharmaceuticals, Inc (161630033)