Label: COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit
- NDC Code(s): 68016-879-48
- Packager: Chain Drug Consortium, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 24, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts - Day Time
- Drug Facts - Night Time
- Purpose - Day Time
- Purpose - Night Time
- Uses - Day Time
- Uses - Night Time
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Warnings - Day Time
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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Warnings - Night Time
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hrs, which is the maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
Sore throat warning: If sore throat is severe, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea, or vomiting, see a doctor promptly.
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Do not use - Day Time
- 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.
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Do not use - Night Time
- 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 sleep
- Ask a doctor before use if you have - Day Time
- Ask a doctor before use if you have - Night Time
- Ask a doctor or pharmacist before use if you are - Day Time
- Ask a doctor or pharmacist before use if you are - Night Time
- When using this product,
- When using this product - Night Time
-
Stop use and ask a doctor if - Day Time
-
you get nervous, dizzy or sleepless
-
symptoms get worse or last more than 5 days (children) or 7 days (adults)
-
fever gets worse or lasts more than 3 days
-
redness or swelling is present
-
new symptoms occur
-
cough comes back, or occurs with rash or headache that lasts.
These could be signs of a serious condition.
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- Stop use and ask a doctor if - Night Time
- If pregnant or breast-feeding,
- If pregnant or breast-feeding, - Night Time
- Keep out of reach of children. - Day Time
- Keep out of reach of children. - Night Time
-
Directions - Day Time
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
adults & children 12 yrs & over
2 capsules with water every 4 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
-
Directions - Night Time
- take only as directed – see Overdose warning
- do not exceed 4 doses per 24 hours
adults & children 12 yrs & over
2 capsules with water every 6 hrs
children 4 to under 12 yrs
ask a doctor
children under 4 yrs
do not use
when using other Daytime or Nighttime products, carefully read each label to ensure correct dosing
- Other information - Day Time
- Other information - Night Time
- Inactive ingredients - Day Time
- Inactive ingredients - Night Time
- Questions or comments?
-
PACKAGE LABEL-PRINCIPAL DISPLAY PANEL 16 FL OZ (474 mL Bottle)
NDC 68016-879-18
Premier Value®
COMPARE TO THE ACTIVE INGREDIENTS IN
VICKS® DAYQUIL® AND VICKS® Nyquil® COLD &
FLU MULTI-SYMPTOM RELIEF LIQUICAPS®Non-Drowsy Multi-Symptom
Daytime Nighttime
COLD & FLU RELIEF
Acetaminophen, Acetaminophen,
Dextromethorphan HBr and Dextromethorphan HBr,
Phenylephrine HCl Capsules Doxylamine Succinate Capsules
325 mg/10 mg/5 mg 325 mg/15 mg/6.25 mg
• Aches, Fever & Sore Throat • Aches, Fever & Sore Throat
• Nasal Congestion • Sneezing, Runny Nose
• Cough • Cough
32 Capsules 16 Capsules
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INGREDIENTS AND APPEARANCE
COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF
acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68016-879 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68016-879-48 1 in 1 PACKAGE; Type 0: Not a Combination Product 07/12/2019 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 32 Part 2 8 BLISTER PACK 16 Part 1 of 2 DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SORBITOL (UNII: 506T60A25R) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE (orange to reddish orange) Score no score Shape OVAL Size 20mm Flavor Imprint Code Q01 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 16 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/12/2019 Part 2 of 2 NIGHTTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsuleProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) GELATIN, UNSPECIFIED (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SHELLAC (UNII: 46N107B71O) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 20mm Flavor Imprint Code Q07 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 CARTON 1 2 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/12/2019 Labeler - Chain Drug Consortium, LLC (101668460) Registrant - Aurohealth LLC (078728447) Establishment Name Address ID/FEI Business Operations APL HEALTHCARE LIMITED 650844777 MANUFACTURE(68016-879)