Daytime Cold/Flu Relief Softgels

Manufacturer
Pharmacy Value Alliance, LLC | AptaPharma Inc.
Effective date
2022-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:43:58

Label at a glance#

ProductDaytime Cold/Flu Relief Softgels
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

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

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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.

OTC - DO NOT USE SECTION

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.

OTC - ASK DOCTOR SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

When using this productdo not use more than directed.

OTC - STOP USE SECTION

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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information
• Store at room temperature 20-25oC (68-77oF)
• avoid excessive heat

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

Principal Display Package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 880-16DayTime 880-16

DayTime 880-24DayTime 880-24

res

Products#

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DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-88068016-880-16, 68016-880-24

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8aa3516a-2d47-42bf-a861-4854ec4e07774d268cf9-fd71-4e61-b874-790b123bd3a02022-12-18WarningsExact identifier
spl id: 8aa3516a-2d47-42bf-a861-4854ec4e0777
spl set id: 4d268cf9-fd71-4e61-b874-790b123bd3a0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.