Label: COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF- acetaminophen, dextromethorphan hbr, phenylephrine hcl liquid
- NDC Code(s): 68016-236-08, 68016-236-12
- 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 adult/child takes:
• more than 4doses in 24 hours, which is the maximum daily amount
for this product • with other drugs containing acetaminophen
• 3or more alcoholic drinks everyday while using this productAllergy 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
2days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly. -
DO NOT USE
Do not use • 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 a 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 pharmacists. - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WHEN USING
-
STOP USE
Stop use and ask a doctor if • you get nervous, dizzy or sleepless
• new symptoms occur • fever gets worse or lasts more than 3days
• pain or cough gets worse or lasts more than 5days (children) or
7days (adults) • redness or swelling is present
• cough comes back or occurs with rash or headache that lasts.
These could be signs of a serious condition. - PREGNANCY OR BREAST FEEDING
-
OVERDOSAGE
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. - Keep this and all drugs out of the reach of children.
-
DOSAGE & ADMINISTRATION
Directions
• take only as recommended (see overdose warning) • use dosage
cup or tablespoon (TBSP) • do not exceed 4doses per 24 hoursage dose
adults and children 30 mL (2 TBSP)
12 years and over every 4hourschildren 6 to 15 mL (1 TBSP)
under 12 years every 4 hourschildren 4 years to ask a doctor
under 6 yearschildren under 4 years do not use
• When using Day Time and Night Time products, carefully
read each label to ensure correct dosing. - OTHER SAFETY INFORMATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
-
QUESTIONS
Questions?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 19087If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund. -
Principal Display Panel
Premier® Value
COMPARE TO THE ACTIVE
INGREDIENTS IN
VICKS® DAYQUIL®*
COLD & FLU
Day Time Multi-Symptom ReliefAcetaminophen...... Pain Reliever/Fever Reducer
Dextromethorphan Hsr...... Cough Suppressant
Phenylephrine HCI........Nasal DecongestantNon-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®.
DISTRIBUTED BY: PHARMACY VALUE ALLIANCE, LLC
407 EAST LANCASTER AVENUE, WAYNE PA 19087If for any reason you are not satisfied with this product, please
return It to the store where purchased for a full refund.LR-028
REV-01
Product Label - 8 FL OZ
Product Label - 12 FL OZ
Premier Value Cold & Flu Day Time Multi-Symptom Relief
-
INGREDIENTS AND APPEARANCE
COLD AND FLU DAY TIME MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-236 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SUCROSE (UNII: C151H8M554) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-236-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 10/01/2018 2 NDC:68016-236-12 354 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(68016-236)