NDC | 68016-144-00, 68016-144-01 |
Set ID | fc39b8dd-a4bd-4b40-accf-edd248a0b4fa |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Consortium, LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART343 |
- Active ingredients
- Purpose
- Keep out of reach of children
- Uses
-
Warnings
Failure to follow these warnings could result in serious consequences
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take * more than 4 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. -
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
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Overdose warning
- Directions
- Other information
- Inactive ingredients
- Questions?
-
Product Label
NDC 68016-144-01
COMPARE TO THE ACTIVE INGREDIENTS IN VICKS® NYQUIL®
Premier Value®
Original
Night-Time
MULTI-SYMPTOM COLD/FLU RELIEF
Acetaminophen……Pain Reliever/Fever Reducer
Dextromethorphan HBr……Cough Suppressant
Doxylamine Succinate ……………Antihistamine
12 FL OZ (354 mL)
INDEPENDENTLY TESTED SATISFACTION GUARANTEED PV
DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
*This product is not manufactured or distributed by Procter and Gamble, owner of the registered trademark Vicks® NyQuil®
If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.
DISTRIBUTED BY
CHAN DRUG CONSORTIUM
3301 NW BOCO RATON BLVD
SUITE 101, BOCA RATON FL 33431
LR-024 -
INGREDIENTS AND APPEARANCE
NIGHT-TIME ORIGINAL MULTI-SYMPTOM COLD/FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-144 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:68016-144-00 236 mL in 1 BOTTLE 2 NDC:68016-144-01 354 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 09/01/2012 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(68016-144)