NDC | 68016-113-06 |
Set ID | e119fafe-9d50-4555-9bd9-389e4a1e2718 |
Category | HUMAN OTC DRUG LABEL |
Packager | Chain Drug Consortium, LLC |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active Ingredients
- Purposes
-
Uses
temporarily relieves these common cold/flu symptoms: • minor aches and pains
• headache • muscular aches • sore throat • fever • runny nose and sneezing
• itchy nose or throat • coughs • cough due to minor throat and bronchial irritation
• itchy, watery eyes due to hay fever or other upper respiratory allergies -
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur
if you take: • more than 4 doses (8 tablespoonfuls or 120 mL) in 24 hours, which is the
maximum daily amount • with other drugs containing acetaminophen
• 3 or more alcoholic drinks everyday while using this product
Sore throat warning: Severe or persistent sore throat or sore throat that occurs with high
fever, headache, rash, nausea, and vomiting may be serious. Ask a doctor right away.
Do not use more than 2 days or give to children under 12 years of age unless directed
by a doctor. -
Do Not Use
• to make a child sleepy • if you are on a sodium-restricted diet
• 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 two
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.
• with any other drug containing acetaminophen (prescription or non-prescription).
If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. - Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are taking
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding
-
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the recommended dose (overdose) could cause
serious health problems, including liver damage. In case of accidental overdose, seek
professional assistance or contact a Poison Control Center immediately. Quick medical
attention is critical for adults as well as for children even if you do not notice any signs
or symptoms. -
Directions
• use dosage cup or tablespoon (TBSP)
• take only as recommended (see overdose warning)
• do not exceed 4 doses per 24 hoursage dose
adults and children 12 years and over................2 TBSPS (30 ml) every 6 hours
children 4 years to under 12 years.......................do not use unless directed by a doctor
children under 4 years..........................................do not use• When using Day Time and Night Time products,
carefully read each label to ensure correct dosing. - Other Information
- Inactive Ingredients
-
Principal Display Panel
Compare to the Active Ingredients in Vicks Nyquil
Premier Value
Cherry Night Time Multi Symptom Cold and Flu Relief
Acetaminophen...Pain Reliever and fever reducer
Dextromethorphan HBr....Cough suppressant
Doxylamine Succinate......Antihistamine
See new dosing and warning information
10 percent alcohol
Premier Value Guarantee
6 fl oz 177mL - Package Label
-
INGREDIENTS AND APPEARANCE
NIGHT TIME PSEUDO-FREE
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM ANHYDROUS (UNII: I4807BK602) TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color Score Shape Size Flavor CHERRY (Nyquil Type Cherry) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-113-06 177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 04/13/2010 Labeler - Chain Drug Consortium, LLC (101668460)