Label: COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
- NDC Code(s): 68016-239-08, 68016-239-12
- Packager: Pharmacy Value Alliance, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 29, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver
damage may occur if you take
• more than 4,000 mg of Acetaminophen 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.Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include: • skin reddening • blisters • rash
If askin reaction occurs, stop use and seek medical help right away.Sore throat warning: If sore throat is severe, persists for more than
two days, is accompanied or followed by fever, headache, rash,
nausea, or vomiting, consult a doctor promptly. -
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 -
ASK DOCTOR
Ask a doctor before use if you have
• a sodium restricted diet • liver disease • glaucoma
• cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with
smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland. - ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if • redness or swelling is present
• symptoms do not get better within 7 days or are accompanied by a fever
• fever gets worse or lasts more than 3 days • new symptoms occur
• cough lasts more than 7 days, comes back, or occurs with fever, rash,
or headache that lasts. These could be signs of a serious condition. - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- OVERDOSAGE
-
DOSAGE & ADMINISTRATION
Directions • take only as recommended-see Overdose warning
• Use dose cup or tablespoon (TBSP)
• do not exceed 4 doses per 24 hoursadults and children 12 30 mL (2 TBSP)
years and over every 6 hourschildren 4 to ask a doctor
under 12 yearschildren under 4years do not use
• If taking Night Time at night and Day Time during the day,
limit total to 4 doses per 24 hours. - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Principal Display Panel
Premier® Value
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® NYQUIL®*
Original Flavor
COLD & FLU
Night-time Multi-Symptom ReliefAcetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hbr...... Cough Suppressant
Doxylamine Succinate........AntihistamineNon-drowsy
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDDO NOT USE IF IMPRINTED SHRINK BAND IS MISSING OR BROKEN
Failure to follow these warnings could result in serious consequencesQuestions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
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: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087LR-023
REV-01
Product label - 8 OZ Package
Product label - 12 OZ Package
Premier® Value Cold & Flu Night-time Multi-Symptom Relief Original
-
INGREDIENTS AND APPEARANCE
COLD AND FLU NIGHT TIME MULTI-SYMPTOM RELIEF ORIGINAL
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-239 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 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, UNSPECIFIED (UNII: 3WJQ0SDW1A) 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:68016-239-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 2 NDC:68016-239-12 354 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 10/01/2018 Labeler - Pharmacy Value Alliance, LLC (101668460) Registrant - AptaPharma Inc. (790523323) Establishment Name Address ID/FEI Business Operations AptaPharma Inc. 790523323 manufacture(68016-239)