Label: CHILDRENS SILAPAP- acetaminophen liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 50090-4466-0 - Packager: A-S Medication Solutions
- This is a repackaged label.
- Source NDC Code(s): 54838-144
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated August 27, 2019
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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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.
Do not use
- 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.
- if the user is allergic to acetaminophen or any of the inactive ingredients in this product
- more than 5 doses in 24 hours, which is the maximum daily amount
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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) - do not take more than directed (see overdose warning).
- Inactive ingredients
- Questions
- HOW SUPPLIED
- Acetaminophen
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INGREDIENTS AND APPEARANCE
CHILDRENS SILAPAP
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50090-4466(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:50090-4466-0 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/14/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 09/05/1994 Labeler - A-S Medication Solutions (830016429) Establishment Name Address ID/FEI Business Operations A-S Medication Solutions 830016429 RELABEL(50090-4466)
