Label: CHILDRENS SILAPAP- acetaminophen liquid
- NDC Code(s): 63187-294-04
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 54838-144
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 1, 2024
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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Warnings
Liver Warning:This product contains acetaminophen. Severe liver damage may occur if you take:
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- more than 5 doses in 24 hours, which is the maximum daily amount
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- with other drugs containing acetaminophen
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- 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.
Do not use
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- with any other product drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- if the user is allergic to acetaminophen or any of the inactive ingredients in this product
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Directions
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- do not take more than directed (see overdose warning).
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- if needed, repeat dose every 4 hours or as directed by a doctor
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- 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
- Questions
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INGREDIENTS AND APPEARANCE
CHILDRENS SILAPAP
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63187-294(NDC:54838-144) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY (cherry flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63187-294-04 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 12/01/2018 05/31/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 09/05/1994 05/31/2024 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 REPACK(63187-294) , RELABEL(63187-294)