Daytime Nighttime Cold Flu Relief

Manufacturer
Safeway, Inc.
Effective date
2018-12-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:39:11

Label at a glance#

ProductDaytime Nighttime Cold Flu Relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE
Label structure12 sections

Indications and uses

temporarily relieves common cold and flu symptoms: sore throat headache minor aches and pains fever cough due to minor throat and bronchial irritation nasal congestion (Daytime only) runny nose and sneezing (Nighttime only)

Dosage and administration

do not take more than directed (see Overdose warning) do not take more than 4 doses in 24 hours swallow whole; do not crush, chew, or dissolve  Daytime:  adults and children 12 years and over: take 2 softgels with water every 4 hours. Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours. children under 12 years: do not use 

Storage and handling

store at room temperature 15°-30°C (59°-86°F) avoid excessive heat

Label contents#

Full prescribing information#

Active ingredients in Daytime (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Active ingredients in Nighttime (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg

Dextromethorphan HBr 15 mg

Doxylamine Succinate 6.25 mg

Purpose for Daytime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Nasal decongestant

Purpose for Nighttime

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves common cold and flu symptoms:
    • sore throat
    • headache
    • minor aches and pains
    • fever
    • cough due to minor throat and bronchial irritation
    • nasal congestion (Daytime only)
    • runny nose and sneezing (Nighttime only)

Warnings

WARNINGS SECTION

Liver warning: These products contain acetaminophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using these products

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • to make a child sleep (Nighttime only)
  • 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

OTC - ASK DOCTOR SECTION

  • liver disease
  • cough that occurs with too much phlegm (mucus)
  • trouble urinating due to an enlarged prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma, emphysema, and (for Nighttime only) chronic bronchitis
  • glaucoma (Nighttime only)
  • diabetes (Daytime only)
  • heart disease (Daytime only)
  • thyroid disease (Daytime only)
  • high blood pressure (Daytime only)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers (Nighttime only)

When using this product,

OTC - WHEN USING SECTION

do not exceed recommended dosage.

In addition, when using Nighttime:

  • excitability may occur, especially in children
  • avoid alcoholic drinks
  • marked drowsiness may occur
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occur (Daytime only)
  • pain, cough, and (for Daytime only) nasal congestion gets worse or lasts more than 7 days
  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Overdose warning: Taking more than the recommended dose can cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed (see Overdose warning)
  • do not take more than 4 doses in 24 hours
  • swallow whole; do not crush, chew, or dissolve 

Daytime: adults and children 12 years and over: take 2 softgels with water every 4 hours.

Nighttime: adults and children 12 years and over: take 2 softgels with water every 6 hours.

  • children under 12 years: do not use 

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature 15°-30°C (59°-86°F)
  • avoid excessive heat

Inactive ingredients in

INACTIVE INGREDIENT SECTION

Daytime butylated hydroxyanisole, butylated hydroxytoluene, edible white ink, FD&C red #40*, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

*may contain this ingredient

Nighttime D&C yellow #10, edible white ink, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitan, sorbitol

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-723-3929 Monday-Friday 7AM-6PM PST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Non-Drowsy Daytime Cold & Flu Relief

Acetaminophen 325 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 10 mg - Cough Suppressant

Phenylephrine HCl 5 mg - Nasal Decongestant

Compare to Vicks® DayQuil® LiquiCaps® active ingredients†

  • Alcohol Free
  • Antihistamine Free

Nighttime Cold & Flu Relief

Acetaminophen 325 mg - Pain Reliever/Fever Reducer

Dextromethorphan HBr 15 mg - Cough Suppressant

Doxylamine succinate 6.25 mg - Antihistamine

Compare to Vicks® NyQuil® LiquiCaps® active ingredients†

  • Alcohol Free

SOFTGELS Daytime Nighttime

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

DISTRIBUTED BY SAFEWAY INC.,

P.O. BOX 99, PLEASANTON, CA 94566-0009

1-888-SAFEWAY / www.safeway.com

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.

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Safeway Daytime and Nighttime Cold and Flu Relief Softgels
Safeway Daytime and Nighttime Cold and Flu Relief Softgels

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D2
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH2
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI22
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ2
ACETAMINOPHENACTIVE MOIETY362O9ITL9D2
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS2
DOXYLAMINEACTIVE MOIETY95QB77JKPL2
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV2
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U2
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A82
GELATININACTIVE INGREDIENT2G86QN327L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
POVIDONESINACTIVE INGREDIENTFZ989GH94E2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SORBITANINACTIVE INGREDIENT6O92ICV9RU2
SORBITOLINACTIVE INGREDIENT506T60A25R2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21130-49021130-490-48

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 463 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3JELLY / TOPICAL20 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION, SOLUTION / SUBCUTANEOUS4.7 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET, DELAYED RELEASE / ORAL53 mgExact identifier — unii candidate
30 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, ORALLY DISINTEGRATING / ORAL12 mgExact identifier — unii candidate
34 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, COATED / ORAL0.1 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED / ORAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KOINTMENT / TOPICAL57 mgExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RINJECTION / INTRASYNOVIAL45 %w/vExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8FILM / SUBLINGUAL0.03 mgExact identifier — unii candidate
34 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSUSPENSION, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
31 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCAPSULE, LIQUID FILLED / ORAL0.1 mgExact identifier — unii candidate
32 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RPASTE / DENTAL14.6 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSOLUTION / RECTALNAExact identifier — unii candidate
31 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
34 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KCREAM / VAGINAL0.05 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GSHAMPOO / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
SORBITOLSORBITOL506T60A25ROINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSPRAY, METERED / NASAL0.1 mg/1mlExact identifier — unii candidate
32 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ECAPSULE, DELAYED RELEASE PELLETS / ORAL32 mgExact identifier — unii candidate
30 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, ORALLY DISINTEGRATING / ORAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION, CONCENTRATE / ORAL200 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2USUSPENSION / ORAL2.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
31 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GLOTION / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, CHEWABLE / ORAL24 mgExact identifier — unii candidate
44 equally ranked IID candidates
SORBITOLSORBITOL506T60A25RTABLET / ORAL337.28 mgExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDFILM / SUBLINGUAL0.07 mgExact identifier — unii candidate
37 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UFILM / SUBLINGUAL0.08 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION, EXTENDED RELEASE / ORAL1000 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KGEL / TOPICAL8 mgExact identifier — unii candidate
32 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER, FOR SUSPENSION / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UTABLET, FILM COATED / ORAL0.4 mgExact identifier — unii candidate
24 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / TOPICAL5.28 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
44 equally ranked IID candidates

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
2379a575-2c9b-42f3-aedb-6770848b09ad0d520d13-046a-4151-847c-0a6cc2ae9e5a2018-12-26WarningsExact identifier
spl id: 2379a575-2c9b-42f3-aedb-6770848b09ad
spl set id: 0d520d13-046a-4151-847c-0a6cc2ae9e5a

Reported adverse events (FAERS/openFDA)#

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