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 Rebel Distributors Corp. 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.
Otc - Active Ingredient
Active Ingredient: Acetaminophen 160 mg (in each 5 mL = 1 teaspoonful)
Otc - Purpose
Purpose: Pain reliever/fever reducer
Indications & Usage
Uses temporarily relieves minor aches and pains due to: the common cold
- flu
- headache
- sore throat
- toothache
- temporarily reduces fever
Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 5 of the recommended doses per day
- 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 you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers.
Otc - Do Not Use
Do not use
- with any other product containing acetaminophen.
Otc - When Using
When using this product
- do not exceed recommended dose (see overdose warning)
Otc - Stop Use
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
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.
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 (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)
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
19 West Street
Spring Valley, NY 10977
USA
Repackaged by:
Rebel Distributors Corp
Thousand Oaks, CA 91320
Package Label.Principal Display Panel
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