Otc - Active Ingredient
Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)
The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Childrens Silapap (NDC 21695-244). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)
Purpose: Pain reliever/fever reducer
Uses temporarily relieves minor aches and pains due to: the common cold
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 you consume 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
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 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 (5 mL) |
| children 4-5 years (36-47 lbs) | 1 1/2 teaspoonfuls (7.5 mL) |
| children 6-8 years (48-59 lbs) | 2 teaspoonfuls (10 mL) |
| children 9-10 years (60-71 lbs) | 2 1/2 teaspoonfuls (12.5 mL) |
| children 11 years (72-95 lbs) | 3 teaspoonfuls (15 mL) |
| adults & children 12 years & older | 4 teaspoonfuls (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
19 West Street
Spring Valley, NY 10977
USA
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
* Please review the disclaimer below.