DAYTIME COLD/FLU RELIEF SOFTGELS- acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled 
Pharmacy Value Alliance, 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/Flu Relief Softgels

DRUG FACTS

Active ingredients (in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Phenylephrine HCl 5 mg

Purpose
Acetaminophen …………….….Pain reliever/fever reducer
Dextromethorphan HBr .....Cough suppressant
Phenylephrine HCI ............Nasal decongestant

Uses temporarily relieves common cold/flu
symptoms: • nasal congestion • cough due to minor throat
& bronchial irritation • sore throat • headache
• minor aches & pains • fever

Warnings 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 every day while using this product
Allergy Alert: Acetaminophen may cause severe skin
reactions. Symptoms may include:
• skin reddening • blisters • rash
If a skin reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, lasts more than
2 days, occurs with or is followed by fever, headache, rash,
nausea, or vomiting, consult a doctor promptly.

Do not use • 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.

Ask a doctor before use if you have • liver disease • heart
disease • thyroid disease • diabetes • high blood pressure
• trouble urinating due to an enlarged prostate gland
• cough that occurs with too much phlegm (mucus)
• persistent or chronic as occurs with smoking, asthma, or
emphysema

Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin.

When using this productdo not use more than directed.

Stop use and ask a doctor if
• 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.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.
In case of accidental overdose, get medical help or contact a
Poison Control Center right away. Quick medical attention is
critical for adults as well as children, even if you do not notice
any signs or symptoms.

Directions

• take only as recommended (see Warnings)
• do not exceed 4 doses per 24 hours

 adults & children 12 years & over 2 softgel with water every 4 hours
 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
• Store at room temperature 20-25oC (68-77oF)
• avoid excessive heat

Inactive ingredients FD&C Red #40, FD&C Yellow #6,
gelatin, Glycerin, Polyethylene glycol, Povidone, Propylene glycol,
Purified water, Sorbitol sorbitan solution Titanium dioxide

Questions? Call weekdays from 9:30 am to 4:30 pm EST.
1-877-798-5944

Principal Display Package

Premier
Value®


*COMPARE TO THE ACTIVE INGREDIENTS
IN VICKS® DAYQUIL® LIQUICAPS®

Non-Drowsy

Daytime

COLD/FLU RELIEF
Acetaminophen / Dextromethorphan HBr / Phenylephrine HCl

• Aches, Fever & Sore Throat
• Nasal Congestion
• Cough

Alcohol - Free

Antihistamine - Free

16 Softgels

**This product is not manufactured or distributed by
Procter & Gamble, owner of the registered trademark
Vicks® DayQuil® LiquiCaps®.

Distributed By:
Pharmacy Value Alliance, LLC
407 East Lancaster Avenue,
Wayne, Pa 19087

   INDEPENDENTLY TESTED
                PV
SATISFACTION GUARANTEED

If for any reason you are not completely satisfied with
this product, please return it to the store
where purchased for a full refund.

TAMPER EVIDENT: DO NOT USE IF
CARTON IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS
ANY SIGNS OF TAMPERING.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT
INFORMATION

BX-094

   9
987542
 1/20

DayTime 880-16

DayTime 880-24

res

DAYTIME COLD/FLU RELIEF SOFTGELS 
acetaminophen, dextromethorphan hbr, phenylephrine hcl capsule, liquid filled
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-880
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
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
SORBITAN (UNII: 6O92ICV9RU)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
Colororange (to red) Scoreno score
ShapeOVALSize20mm
FlavorImprint Code 604
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-880-162 in 1 PACKAGE02/28/2020
18 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:68016-880-242 in 1 PACKAGE02/28/2020
212 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34102/28/202012/31/2023
Labeler - Pharmacy Value Alliance, LLC (101668460)
Registrant - AptaPharma Inc. (790523323)
Establishment
NameAddressID/FEIBusiness Operations
AptaPharma Inc.790523323manufacture(68016-880)

Revised: 12/2022
 
Pharmacy Value Alliance, LLC