Label: NITE-TIME COLD/FLU MEDICINE- acetaminophen liquid
- NDC Code(s): 76281-501-25, 76281-501-28
- Packager: AptaPharma Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 11, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
- Keep Out Of Reach Of Children
- Uses
-
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage
may occur if you take ● more than 4 doses (30 mL each) in 24 hours, which is
the maximum daily amount for this product ● with other drugs containing
acetaminophen ● 3 or more alcoholic drinks everyday 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.
- Ask A Doctor
- Ask A Doctor Or Pharmacist
- When Using This Product
- Stop Use And Ask A Doctor
- Pregnant Or Breast-Feeding
- Overdose Warning
-
Directions
Directions
- take only as recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
adults and children 12 years and over 30 mL (2TBSP) every 6 hours
children 4 to under 12 years ask a doctor
children under 4 years do not use
- If taking Nite Time at night and Day Time during the day, limit total to 4 doses per 24 hours
- Other Information
- Inactive Ingredients
-
Do Not Use
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
- to make a child sleepy
-
Package Label - Night Time Cold & Flu Relief
NDC 76281-501-28
AP SAFE
*COMPARE TO
the active ingredients in
VICKS® NYQUIL®Night Time
Acetaminophen – Pain Reliever/Fever Reducer
Dextromethorphan HBr – Cough Suppressant
Doxylamine Succinate – AntihistamineMulti-Symptom
Cold & Flu ReliefOriginal Flavor
12 FL OZ (354 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequences
*This product is not manufactured or distributed by Procter &
Gamble, owner of the registered trademark Vicks® NyQuil®.Manufactured by: AptaPharma Inc.,
1533 Union Ave., Pennsauken, NJ 0811012 OZ
6 OZ
res
-
INGREDIENTS AND APPEARANCE
NITE-TIME COLD/FLU MEDICINE
acetaminophen liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76281-501 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76281-501-28 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 2 NDC:76281-501-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/09/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 03/09/2018 Labeler - AptaPharma Inc. (790523323) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(76281-501)