NIGHTTIME COLD AND FLU RELIEF - acetaminophen, dextromethorphan hbr and doxylamine succinate capsule 
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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NIGHTTIME COLD AND FLU

Multi-Symptom

Drug Facts

Active ingredients (in each capsule)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Antihistamine

Uses

temporarily relieves common cold/flu symptoms:

Warnings

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

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

These could be signs of a serious condition.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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


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

Inactive ingredients

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 Cpsules Bottle

NDC 68016-878-16

Premier Value®


COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® NYQUIL® COLD & FLU
NIGHTTIME RELIEF LIQUICAPS®

Multi-Symptom

Nighttime
COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Doxylamine Succinate Capsules

325 mg/15 mg/6.25 mg 


16 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 Cpsules Bottle

NIGHTTIME COLD AND FLU RELIEF 
acetaminophen, dextromethorphan hbr and doxylamine succinate capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-878
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
1NDC:68016-878-168 in 1 CARTON07/12/2019
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-878-2412 in 1 CARTON07/12/2019
22 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
Labeler - Chain Drug Consortium, LLC (101668460)
Registrant - Aurohealth LLC (078728447)
Establishment
NameAddressID/FEIBusiness Operations
APL HEALTHCARE LIMITED650844777MANUFACTURE(68016-878)

Revised: 12/2020
Document Id: 09fd180e-7a64-441e-8862-557916982d0e
Set id: 1deb60f3-e9be-4756-b0c1-527ef00dc741
Version: 2
Effective Time: 20201211
 
Chain Drug Consortium, LLC