DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF - acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride 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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DAYTIME COLD AND FLU

Multi-Symptom Relief

Drug Facts

Active ingredients (in each capsule)

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

Purpose

Pain reliever/fever reducer
Cough suppressant
Nasal decongestant

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

taking the blood thinning drug warfarin

When using this product,

do not use more than directed.

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 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

Other information

Inactive ingredients

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

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 capsule Bottle

NDC 68016-877-16

Premier Value


COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® DAYQUIL® COLD & FLU
MULTI-SYMPTOM RELIEF LIQUICAPS®*

Multi-Symptom Relief

Daytime
COLD & FLU RELIEF

Acetaminophen, Dextromethorphan HBr and

Phenylephrine HCl Capsules

325 mg/10 mg/5 mg 


16 Capsules

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 16 capsule Bottle

DAYTIME COLD AND FLU MULTI-SYMPTOM RELIEF 
acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-877
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
1NDC:68016-877-168 in 1 CARTON07/12/2019
12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-877-2412 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(68016-877)

Revised: 12/2020
Document Id: 9857ee21-8c34-4c0a-9078-f0029314ce16
Set id: 8cb0d0c8-c565-4c5a-97c5-8250a67e23a8
Version: 2
Effective Time: 20201211
 
Chain Drug Consortium, LLC