NDC | 57243-501-25 |
Set ID | fcd24753-b42b-4d05-8379-0ec0351ab217 |
Category | HUMAN OTC DRUG LABEL |
Packager | Salado Sales, Inc. |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART343 |
- Drug FactsActive ingredients (in each 30 mL dose cup)
- 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 amoun
- with other drugs containing acetaminophen
- 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 ccurs, 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. - more than 4 doses in 24 hours, which is the maximum daily amoun
- 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
- Pregnant Or Breast-Feeding
- Overdose Warning
- Directions
- Other Information
- Inactive ingredients
-
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
-
Product Label
Compare to VICKS® NYQUIL® active ingredients CVP CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU MedicineMulti-Symptom ORIGINAL FLAVOR
Acetaminophen ..........................Aches, Fever and Sore Throat
Dextromethorphan ......................Cough
Doxylamine Succinate ................Sneezing, Runny nose
6 FL OZ (177 mL)
DO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
*This product is not manufactured or distributed by Proctor and Gamble, distributor of Vicks® Nyquil® LR-002
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944
Distributed by: Salado Sales, Inc. P.O. Box 6115 Temple, TX 76503 www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
ORIGINAL FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
-
INGREDIENTS AND APPEARANCE
NITE-TIME COLD/FLU ORIGINAL
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-501 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) 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:57243-501-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/16/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/16/2012 Labeler - Salado Sales, Inc. (009830555) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(57243-501)