Label: NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS- acetaminophen 160mg suspension
- NDC Code(s): 83057-0003-6
- Packager: HBC Pharma, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 October 2, 2023
If you are a consumer or patient please visit this version.
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- Active Ingredient
- Purpose
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Warnings
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child takes ■ more than 5 doses in 24 hours, which is the maximum daily amount for this product
■ with other drugs containing acetaminophen.
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
■ skin reddening ■ blisters ■ rash. If a skin reaction occurs, stop use and seek medical help right away
Sore throat warning: if sore throat is severe, persistent for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting. Consult a doctor promptly.
Do not use
- With any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- If your child is allergic to acetaminophen or any of the inactive ingredients in this product.
Stop use and ask a doctor if
■ pain gets worse or lasts more than 5 days ■ fever gets worse or lasts more than 3 days ■ new symptoms occur ■ redness or swelling is present. These could be signs of a serious condition.
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Directions
Do not give more than directed, this product does not contain directions or complete warnings for adult use, find right dose on
chart below. If possible, use weight to dose; otherwise, use age. Repeat dose every 4 hours while symptoms last, do not give more than 5 times in 24 hours. Attention use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
Weight (lbs) Age (Years) Dose under 24 lbs. under 2 years Ask a doctor 24-35 lbs. 2 - 3 years 5 mL
36-47 lbs. 4-5 years 7.5 48-59 lbs. 6-10 Years 10 mL
60-71 lbs 9-10 years 12.5 mL
72-95 lbs 11 years 15 ml - Other Information
- Inactive Ingredient
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- Package
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INGREDIENTS AND APPEARANCE
NOVALGINA ACETAMINOPHEN PAIN AND FEVER FOR CHILDRENS
acetaminophen 160mg suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83057-0003 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 CORN SYRUP (UNII: 9G5L16BK6N) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) SORBITOL (UNII: 506T60A25R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) FD&C RED NO. 40 (UNII: WZB9127XOA) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Product Characteristics Color Score Shape Size Flavor STRAWBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83057-0003-6 1 in 1 CARTON 07/15/2023 1 125 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 06/08/2023 Labeler - HBC Pharma, LLC (063580631) Establishment Name Address ID/FEI Business Operations Gadal Laboratories, Inc 841305639 manufacture(83057-0003)
