NDC | 57243-502-25 |
Set ID | e6c3e545-b2ad-47f0-8318-c134a8e24f5b |
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 4,000 mg of acetaminophen in 24 hours
- 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 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. -
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
- Pregnant Or Breast-Feeding
- Overdose warning
-
Directions
- take only as recommended-see Overdose warnings
- Use dose cup or tablespoon (TBSP)
- do not exceed 4 doses per 24 hours
adults & children 12 years and over 30 mL (2 TBSP) 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
-
Nite Time Cherry product label
Compare to VICKS® NYQUIL® active ingredients
CVP® CONSUMER VALUE PRODUCTS
Nite-Time COLD/FLU Medicine
Multi-Symptom CHERRY FLAVOR
Acetaminophen • Aches, Fever & 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-003
Questions? Call weekdays from 9:30am to 4:30pm EST 1-877-795-5944LR-003 Rev 02
Distributed by:
Salado Sales, Inc.
P.O. Box 6115 Temple, TX 76503
www.saladosales.com
LOT: EXP:
Peel Here DRUG FACTS CONTINUED ON BACK
CHERRY FLAVOR Nite-Time Multi-Symptom COLD/FLU Medicine- Antihistamine
- Cough Suppressant
- Pain Reliever
- Fever Reducer
-
INGREDIENTS AND APPEARANCE
NITE-TIMECOLD/FLU CHERRY COLD/FLU CHERRY
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57243-502 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) 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) Product Characteristics Color Score Shape Size Flavor CHERRY (CHERRY FLAVOR) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57243-502-25 177 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/31/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/31/2012 Labeler - Salado Sales, Inc. (009830555) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(57243-502)