FDA Label for Childrens Silapap
View Indications, Usage & Precautions
Childrens Silapap Product Label
The following document was submitted to the FDA by the labeler of this product A-s Medication Solutions. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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.
Directions
- 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 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)
Inactive Ingredients
citric acid, D&C red no. 33, FD&C red no. 40, cherry flavor, methylparaben, propylene glycol, saccharin sodium, sodium benzoate, and purified water.
Questions
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
How Supplied
Product: 50090-4466
NDC: 50090-4466-0 118 mL in a BOTTLE, PLASTIC
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