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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 11, 2020
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.
-
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 FINAL part341 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 FINAL part341 07/12/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 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)