COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF- acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate 
Chain Drug Consortium, LLC

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.

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Drug Facts - Day Time

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 10 mg
Phenylephrine HCl USP 5 mg

Drug Facts - Night Time

Active ingredients (in each capsule)

Acetaminophen USP 325 mg
Dextromethorphan HBr USP 15 mg
Doxylamine succinate USP 6.25 mg

Purpose - Day Time

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

Purpose - Night Time

Pain reliever/fever reducer
Cough suppressant
Antihistamine



Uses - Day Time

temporarily relieves common cold/flu symptoms:

Uses - Night Time

temporarily relieves common cold/flu symptoms:

Warnings - Day Time

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

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

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.

Do not use - Day Time

Do not use - Night Time

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

taking the blood thinning drug warfarin

Ask a doctor or pharmacist before use if you are - Night Time

When using this product,

do not use more than directed.

When using this product - Night Time

Stop use and ask a doctor if - Day Time


These could be signs of a serious condition.

Stop use and ask a doctor if - Night Time

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

If pregnant or breast-feeding, - Night Time

ask a health professional before use.

Keep out of reach of children. - Day Time

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Keep out of reach of children. - Night Time

Overdose warning:

Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults & for children even if you do not notice any signs or symptoms.

Directions - Day Time


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


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

citric acid anhydrous, gelatin, glycerin, Neelicert FD & C Red No. 40, Neelicert FD & C Yellow No. 6, noncrystallizing sorbitol solution, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, titanium dioxide

Inactive ingredients - Night Time

D&C Yellow No. 10, gelatin, glycerin, Neelicert FD&C Blue No. 1, polyethylene glycol, povidone, propylene glycol, purified water, shellac glaze, sorbitol sorbitan solution, titanium dioxide

Questions or comments?

call 1-855-274-4122
 
Distributed by:
Pharmacy Value Alliance, LLC

407 East Lancaster Avenue,

Wayne, Pa 19087


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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 48 Capsule Bottle

COLD AND FLU MULTI-SYMPTOM RELIEF/COLD AND FLU NIGHTTIME RELIEF 
acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and doxylamine succinate kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-879
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-879-481 in 1 PACKAGE; Type 0: Not a Combination Product07/12/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 116 BLISTER PACK 32 
Part 28 BLISTER PACK 16 
Part 1 of 2
DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
acetaminophen, dextromethorphan hydrobromide, and phenylephrine hydrochloride capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE10 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGE (orange to reddish orange) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code Q01
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
116 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2019
Part 2 of 2
NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hydrobromide, and doxylamine succinate capsule
Product Information
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE15 mg
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE6.25 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorGREENScoreno score
ShapeOVALSize20mm
FlavorImprint Code Q07
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
18 in 1 CARTON
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34107/12/2019
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777MANUFACTURE(68016-879)

Revised: 12/2020
Document Id: 204453c2-37db-4576-ac41-950e0642e52c
Set id: f9c3c12b-4efa-4ec4-a156-c403aff81753
Version: 2
Effective Time: 20201211
 
Chain Drug Consortium, LLC