Label: ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER- acetaminophen 325 mg and dextromethorphan hbr 10 mg oral liquid day time kids liquid
- NDC Code(s): 87078-331-01, 87078-331-16
- Packager: MEDWISE LIFESCIENCES INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 15, 2026
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- Official Label (Printer Friendly)
- Active ingredients (in each 10 mL)
- Purposes
- Uses
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Warnings
Liver warning:This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (20 mL each) in 24 hrs, which is the maximum daily amount for this product
- child takes more than 4 doses (10 mL each) in 24 hrs, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
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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 you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- take only as directed
- do not exceed 4 doses per 24 hrs
- do not give more than directed (see liver warning)
- follow the instruction given on this carton for your eash use
- mL=mililiter
Age (years) Dose (Sachet) Adults & Children 12 yrs & Over 2 sachets (20 mL*) every 4 hrs Children 6 to under 12 yrs 1 sachet (10 mL*) every 4 hrs Children 4 to under 6 yrs ask a doctor Children under 4 yrs do not use - Other Information
- Inactive Ingredients
- Question or Comments?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ONESSIP DAY TIME KIDS COLD AND COUGH PLUS FEVER
acetaminophen 325 mg and dextromethorphan hbr 10 mg oral liquid day time kids liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:87078-331 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 10 mL ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 10 mL Inactive Ingredients Ingredient Name Strength SODIUM CITRATE (UNII: 1Q73Q2JULR) XANTHAN GUM (UNII: TTV12P4NEE) SODIUM BENZOATE (UNII: OJ245FE5EU) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) EDETATE DISODIUM (UNII: 7FLD91C86K) SODIUM SACCHARIN (UNII: SB8ZUX40TY) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SUCRALOSE (UNII: 96K6UQ3ZD4) GLYCERIN (UNII: PDC6A3C0OX) SORBITOL SOLUTION 70% (UNII: 8KW3E207O2) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color purple Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:87078-331-16 16 in 1 CARTON 05/15/2026 1 NDC:87078-331-01 10 mL in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 05/15/2026 Labeler - MEDWISE LIFESCIENCES INC. (140161518)

