dg health cold and flu relief

Manufacturer
Dolgencorp, LLC
Effective date
2018-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-02 00:40:14

Label at a glance#

Productdg health cold and flu relief
Active ingredientACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves common cold/flu symptoms: • nasal congestion • sinus congestion and pressure • minor aches and pains • headache • fever • sore throat • runny nose and sneezing • cough due to minor throat and bronchial irritation • cough to help you sleep • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose

Dosage and administration

• take only as directed – see Overdose warning • only use the dose cup provided • do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use • each 30 mL contains: sodium 12 mg • store at 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each 30 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Doxylamine succinate 12.5 mg

Phenylephrine HCl 10 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Antihistamine

Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves common cold/flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • headache
  • fever
  • sore throat
  • runny nose and sneezing
  • cough due to minor throat and bronchial irritation
  • cough to help you sleep
  • reduces swelling of nasal passages
  • promotes nasal and/or sinus drainage
  • temporarily restores freer breathing through the nose

Warnings

WARNINGS SECTION

Liver warning: This product contains 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 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, 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

  • 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.
  • if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking sedatives or tranquilizers
  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery
  • alcohol, sedatives, and tranquilizers may increase drowsiness

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you get nervous, dizzy or sleepless
  • pain, nasal congestion, or cough 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: 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 as well as for children even if you do not notice any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as directed – see Overdose warning
  • only use the dose cup provided
  • do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 4 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Other information

STORAGE AND HANDLING SECTION

  • each 30 mL contains: sodium 12 mg
  • store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxyanisole, edetate disodium, FD&C blue #1, FD&C red #40, flavor, glycerin, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions?

OTC - QUESTIONS SECTION

1-888-309-9030

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SEE NEW WARNINGS

Compare to the active ingredients of Vicks® NyQuil® Severe Cold & Flu

Maximum Strength

Night Time Severe

Cold & Flu Relief

Acetaminophen

Dextromethorphan HBr

Doxylamine Succinate

Phenylephrine HCl

Pain Reliever, Fever Reducer

Nasal Decongestant

Cough Suppressant

Antihistamine

Berry Flavor

ALCOHOL FREE

12 FL OZ (355 mL)

DG Health Cold & Flu Relief Image
DG Health Cold & Flu Relief Image

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9D3
DEXTROMETHORPHAN HYDROBROMIDEACTIVE INGREDIENT9D2RTI9KYH3
DOXYLAMINE SUCCINATEACTIVE INGREDIENTV9BI9B5YI23
PHENYLEPHRINE HYDROCHLORIDEACTIVE INGREDIENT04JA59TNSJ3
ACETAMINOPHENACTIVE MOIETY362O9ITL9D3
DEXTROMETHORPHANACTIVE MOIETY7355X3ROTS3
DOXYLAMINEACTIVE MOIETY95QB77JKPL3
PHENYLEPHRINEACTIVE MOIETY1WS297W6MV3
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2U3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V33
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TY3
SODIUM PHOSPHATE, MONOBASICINACTIVE INGREDIENT3980JIH2SW3
SUCROSEINACTIVE INGREDIENTC151H8M5543
WATERINACTIVE INGREDIENT059QF0KO0R3
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE3

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55910-76355910-763-34, 55910-763-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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 · 442 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDELIXIR / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYSOLUTION / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
34 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
34 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDDOUCHE / VAGINALNAExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TRANSDERMAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UINJECTION / INTRAVENOUSNAExact identifier — unii candidate
24 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / AURICULAR (OTIC)0.1 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET / SUBLINGUAL7 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYFILM, SOLUBLE / BUCCAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION / ORAL100 mg/5mlExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTION / SUBCUTANEOUS47.75 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS13.2 mgExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEELOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
29 equally ranked IID candidates
BUTYLATED HYDROXYANISOLEBUTYLATED HYDROXYANISOLEREK4960K2UCAPSULE, LIQUID FILLED / ORAL4 mgExact identifier — unii candidate
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, CHEWABLE / ORAL84 mgExact identifier — unii candidate
34 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION / INTRAMUSCULAR161 mgExact identifier — unii candidate
9 equally ranked IID candidates
SUCROSESUCROSEC151H8M554POWDER, FOR SOLUTION / ORAL38666 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, COATED / ORAL14.21 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASICSODIUM PHOSPHATE, MONOBASIC3980JIH2SWINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS0.22 mgExact identifier — unii candidate
9 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, LIQUID FILLED / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554CAPSULE / ORAL3568 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEFILM, SOLUBLE / ORAL1 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYTABLET, FILM COATED / ORAL2 mgExact identifier — unii candidate
34 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, LIQUID FILLED / ORAL0.08 mgExact identifier — unii candidate
37 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION, EXTENDED RELEASE / ORAL5400 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
SUCROSESUCROSEC151H8M554SUSPENSION/ DROPS / ORAL3750 mgExact identifier — unii candidate
48 equally ranked IID candidates
SACCHARIN SODIUMSACCHARIN SODIUMSB8ZUX40TYPOWDER, FOR SOLUTION / ORAL199 mgExact identifier — unii candidate
34 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET, COATED / ORAL516.42 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASOLUTION / ORAL38 mgExact identifier — unii candidate
28 equally ranked IID candidates
SUCROSESUCROSEC151H8M554INJECTABLE, LIPOSOMAL / INTRAVENOUS7560 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 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
d68b4e3c-6c18-493e-a21b-3c5b8d9344e6bf0bcb96-ca9e-4a02-b042-4550b9718ce12024-11-06WarningsExact identifier
spl set id: bf0bcb96-ca9e-4a02-b042-4550b9718ce1

Reported adverse events (FAERS/openFDA)#

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