Label: COLD AND FLU NIGHT-TIME MULTI SYMPTOM RELIEF CHERRY- acetaminophen, dextromethorphan hbr, doxylamine succinate liquid
- NDC Code(s): 68016-237-08, 68016-237-12
- 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.
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- 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 a skin 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 ([BSP) • do not exceed
4 doses per 24 hours • If taking Night Time at night and Day
Time during the day, limit total to 4 doses per 24 hours.adults & children 12 30 mL (2 TBSP)
years and over every 6 hourschildren 4 to ask a doctor
under 12 yearschildren under 4 years do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
Principal Display Panel
Premier Value®
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® NYQUIL®*COLD & FLU
Night-time Multi-Symptom ReliefAcetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan HBr...... Cough Suppressant
Doxylamine Succinate....... AntihistamineCherry Flavor
8 FL OZ (237 mL)
INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEEDQuestions? Call weekdays 1-877-798-5944.
*This product is not manufactured or distributed by Proctor &
Gamble, owner of the registered trademark Vicks® NyQuil®.DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087
If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.LR-025 REV 01
Product Label - Cold & Flu Night-time Multi Symptom Relief Cherry - 8 OZ Package
Product Label - Cold & Flu Night-time Multi Symptom Relief Cherry - 12 OZ Package
Premier Value® Cold & Flu Night-time Multi Symptom Relief Cherry
-
INGREDIENTS AND APPEARANCE
COLD AND FLU NIGHT-TIME MULTI SYMPTOM RELIEF CHERRY
acetaminophen, dextromethorphan hbr, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-237 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) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) 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:68016-237-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 2 NDC:68016-237-12 354 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(68016-237)